(152 days)
No
The summary describes a standard dental implant system with various components and materials. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are based on bench testing of mechanical properties.
Yes
The device is described as an "integrated system of endosseous dental implants" intended to "restore a patient's chewing function" and "improve the appearance" by providing prosthetic support for dental restorations. This clearly indicates a medical purpose to treat a condition (loss of teeth/chewing function) and restore a physiological function, which falls under the definition of a therapeutic device.
No
This device is an implant system designed to provide prosthetic support for dental restorations, restoring chewing function. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines physical components made of materials like CP Ti Grade 4, alloy, and POM, which are surgically implanted. This indicates a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations." This describes a surgical implant used in vivo (within the body) to restore function.
- Device Description: The description details the components of a dental implant system (fixtures and abutments) made of materials like CP Ti Grade 4 and alloy. These are physical devices intended for implantation.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with human specimens for diagnostic purposes.
Therefore, the AnyOne Onestage Implant System is a surgical dental implant system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AnyOne Onestage Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following stuations and with the clinical protocols:
-Delayed loading.
-Immediate loading when good
primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
AnyOne Onestage Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients and consists of fixtures and abutments. The dental implants which used in conjunction with other prosthesis restore the lost chewing ability and improve the appearance.
AnyOne Onestage Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the . surface treated by SLA method. It is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity. The fixtures have Octa connection, and various cuff height with consideration for soft tissue level (gingival height). These fixtures can be used the one-stage and two-stage surgical procedure. This device is a tissue level implant.
Dental prosthesis is an abutment of a dental implant system and connecting elements between the dental implant and the restoration. The abutment is fixed to the implant and is permanently or temporary in
contact with the gum in the surgical cavity. These abutments are made of alloy and POM, and intended to be placed on the fixture allows single & multiple prosthetic restorations to restore a patient's chewing function.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular arches (jaw)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The non-clinical testing data which are submitted, referenced, or relied on in this submission support demonstrating substantial equivalence.
Biocompatibility
The biocompatibility evaluation has been performed in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
The additional biocompatibility testing is not required on the AnyOne Onestage Implant System since AnyOne Onestage Implant System has same material composition, manufacturing process and patient contacting parts as predicate device, AnyRidge Octa 1 Implant System (K182448), ExFeel Dental Implant System (K052369), AnyOne Internal Implant System (K123988) and Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment (K19614).
Modified Surface Treatment
The surface treatment evaluation has been performed in accordance with 'Section 11 of Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'.
AnyOne Onestage Implant System has same surface treatment and manufacturing process as predicate device, AnyRidge Octa 1 Implant System (K182448) and ExFeel Dental Implant System (K052369) for the surface treatment of S.L.A and Anodizing, and Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment (K19614) for TiN coating.
Pyrogen and Endotoxin Test
The subject device will not be labeled as "non-pyrogenic", and the endotoxin testing will be conducted on every batch for the subject device with the testing limit of below 0.5 EU/mL in accordance with the USP 39 .
Sterilization validation
Sterilization validating testing has been performed in accordance with ISO 11137 and ISO 17665-1, 2 to verify the sterility assurance level (104). The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980 and the test results validated 5 years shelf life.
Also, the following guidance documents were referred to:
- . Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Performance (Physical Properties) Test
The following bench tests have been performed in accordance with "ISO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment" to evaluate the performance of the subject devices and the test results met the pre-set criteria.
- . Static compression-strength test
- . Fatigue test
No clinical studies are submitted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K052369, K150537, K123988, K160670, K171027, K192614, K182091
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
MegaGen Implant Co., Ltd. % You Kim Chief Researcher DaeGyeong Regulatory Affairs Institute 32. Innovallev-ro Daegu, Dong-gu 41065 REPUBLIC OF KOREA
Re: K210161
Trade/Device Name: AnyOne Onestage Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 20, 2021 Received: May 24, 2021
Dear You Kim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210161
Device Name AnyOne Onestage Implant System
The AnyOne Onestage Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following stuations and with the clinical protocols:
-Delayed loading.
-Immediate loading when good
primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------ |
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3
510(k) Summary for K210161
Date: June 22, 2021
1. Applicant / Submitter
MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun, Daegu, Republic of Korea Tel: + 82-53-222-2828
2. Submission Correspondent
You Jung Kim DaeGyeong Regulatory affairs Institute 32, Innovalley-ro, Dong-gu, Daegu, 41065, Republic of Korea Tel: +82-53-247-2258 Fax: +82-53-247-2254 Email: ra3@dgri.co.kr
3. Device
- Trade Name: AnyOne Onestage Implant System ■ Common Name: Endosseous Dental Implant ■ Classification Name: Endosseous dental implant ■ Classification Product Code: DZE ■ Secondary Product Code: NHA ■ Classification regulation: Class II, 21 CFR 872.3640
Predicate Device 4.
. Primary Predicate Device: K182448- AnyRidge Octa 1 Implant System
. Reference Devices:
K052369 - ExFeel Dental Implant System K150537 - MiNi Internal Implant System K123988 - AnyOne Internal Implant System K160670 - ET US SS Prosthetic System K171027 - Dentis Dental Implant System K192614 - Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment K182091 - Osstem Abutment System
4
5. Description
- AnyOne Onestage Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients and consists of fixtures and abutments. The dental implants which used in conjunction with other prosthesis restore the lost chewing ability and improve the appearance.
- AnyOne Onestage Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the . surface treated by SLA method. It is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity. The fixtures have Octa connection, and various cuff height with consideration for soft tissue level (gingival height). These fixtures can be used the one-stage and two-stage surgical procedure. This device is a tissue level implant.
- . Dental prosthesis is an abutment of a dental implant system and connecting elements between the dental implant and the restoration. The abutment is fixed to the implant and is permanently or temporary in
contact with the gum in the surgical cavity. These abutments are made of alloy and POM, and intended to be placed on the fixture allows single & multiple prosthetic restorations to restore a patient's chewing function. - The proposed AnyOne Onestage Implant System is consisted of the following components. For reference, . all the subject device in this submission are to be added Megagen's existing implant and prosthetic portfolio which had been FDA cleared.
| Content | |||
|---|---|---|---|
| 1. Fixture Products | AnyOne Onestage Fixture | Description AnyOne Onestage Fixture is a substructure of a dental implant system made of titanium and have the interface connection for Internal Octa. It is used in conjunction with other prosthetic and restore lost chewing ability, improve appearance. | |
| Material CP Ti Grade 4 (ASTM F67-13) | |||
| Dimension (Diameter & Length) Ø 3.9 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm | |||
| Ø 4.3 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm | |||
| Ø 4.8 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm | |||
| Ø 5.3 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm | |||
| Gingival (Cuff) Height 1.2, 1.8, 2.2 mm | |||
| 2. Closing Screw & Cover Screw & Healing Abutment | Closing Screw | Description The Closing Screw is used in conjunction with fixture for protecting the inner structure of a fixture, and exposed fixture platform after fixture placement. | |
| Material Ti-6Al-4V ELI (ASTM F136-13) | |||
| Dimension (Diameter & Length) Ø 3.5 x 6.0 mm | |||
| Gingival (Cuff) Height 1.5mm | |||
| Angulation Straight | |||
| Cover Screw | Description The Cover Screw is used in conjunction with fixture for protecting the inner structure of a fixture, and exposed fixture platform after fixture placement. | ||
| Material Ti-6Al-4V ELI (ASTM F136-13) | |||
| Dimension (Diameter & Length) Ø 4.85 x 7.0 mm | |||
| Gingival (Cuff) Height 1.5mm | |||
| Angulation Straight | |||
| Healing Abutment | Description The Healing Abutment is used in conjunction with fixture and helps to form suitable emergence profile during period of gingival healing. | ||
| Material Ti-6Al-4V ELI (ASTM F136-13) | |||
| Dimension (Diameter & Length) Ø 5.5 x 6.5, 7.5, 8.5 mm | |||
| Gingival (Cuff) Height 2.0, 3.0, 4.0 mm | |||
| Angulation Straight | |||
| 3. Fixture Level Prosthesis | Multi Post | Description The Multi Post is used in conjunction with fixture to provide support for cement retained type final prosthesis. It is connected to the Fixture using Multi Post Screw. | |
| Material Ti-6Al-4V ELI (ASTM F136-13) | |||
| Dimension (Diameter & Length) Ø 5.5 x 8.7 mm | |||
| Gingival (Cuff) Height | 1.0 mm | ||
| Post Height | 5.5 mm | ||
| Angulation | Straight | ||
| Multi Post | |||
| Cap | Description | The Multi Post Cap is used to protect Multi Post, minimizes | |
| discomfort of oral cavity and relieve feeling of irritation and | |||
| protect until the prosthesis is produced after the impression | |||
| is taken. | |||
| Material | POM | ||
| Dimension | |||
| (Diameter & Length) | Ø 5.9 x6.5 mm | ||
| Post Height | 5.5 mm | ||
| EZ Post | |||
| Abutment | Description | The EZ Post Abutment is used in conjunction with fixture to | |
| provide support for cement and screw retained type final | |||
| prosthesis. It is connected to the Fixture using Multi Post | |||
| Screw. | |||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | ||
| Dimension | |||
| (Diameter & Length) | Ø 4.8 x 6.2, 7.2,10) 7.7, 8.2, 8.7, 9.2, 9.7, 10.2, 10.7, 11.2, 12.2 | ||
| mm | |||
| Gingival (Cuff) Height | 0.0, 1.0, 2.0, 3.0 mm | ||
| Post Height | 4.0, 5.5, 7.0 mm | ||
| Angulation | Straight | ||
| Angled | |||
| Abutment | Description | The Angled Abutment is used in conjunction with fixture and | |
| used for correcting the prosthetic angulation of implant. It is | |||
| connected to the Fixture using Abutment Screw. | |||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | ||
| Dimension | |||
| (Diameter & Length) | Ø 3.7 x 9.0 mm | ||
| Post Height | 6.5 mm | ||
| Angulation | 15°, 25° | ||
| Gold | |||
| Abutment | Description | The Gold Abutment is used in conjunction with fixture and | |
| used for fabrication of abutment for either screw or cement | |||
| retained restorations by casting with precious metal alloy | |||
| (Gold alloy). It is connected to the Fixture using Multi Post | |||
| Screw. | |||
| Material | Body: Gold Alloy / Sleeve: POM | ||
| Dimension | |||
| (Diameter & Length) | Ø 5.5 x 13.65 mm | ||
| Gingival (Cuff) Height | 1.5 mm | ||
| Post Height | 10.0 mm | ||
| Angulation | Straight | ||
| CCM | |||
| Abutment | Description | The CCM Abutment is used in conjunction with fixture and | |
| used for fabrication of abutment for either screw or cement | |||
| retained restorations by casting with non-precious metal | |||
| alloy (Co-Cr-Mo alloy). It is connected to the Fixture using | |||
| Multi Post Screw. | |||
| Material | Body: Co-Cr-Mo Alloy / Sleeve: POM | ||
| Dimension | |||
| (Diameter & Length) | Ø 5.5 x 13.65 mm | ||
| Gingival (Cuff) Height | 1.5 mm | ||
| Post Height | 10.0 mm | ||
| Angulation | Straight | ||
| Multi Post | |||
| Screw | Description | The Multi Post Screw is used for connecting Fixture to Multi | |
| Post, EZ Post Abutment, Gold Abutment or CCM Abutment | |||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | ||
| Dimension | |||
| (Diameter & Length) | Ø 2.5 x 8.1 mm | ||
| Abutment | |||
| Screw | Description | The Abutment Screw is used for connecting Fixture to Angled | |
| Abutment. | |||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | ||
| Dimension | |||
| (Diameter & Length) | Ø 2.6 x 5.5 mm | ||
| 4. Abutment | |||
| Level | |||
| Prosthesis | Solid | ||
| Abutment | Description | The Solid Abutment is used in conjunction with fixture to | |
| provide support for final prosthesis, and used in cement | |||
| retained restoration only. It is connected to the Fixture by its | |||
| threaded part. | |||
| Material | Ti-6Al-4V ELI (ASTM F136-13) |
5
6
| (Diameter & Length) | ||||||
|---|---|---|---|---|---|---|
| Post Height | 4.0, 5.5, 7.0 mm | |||||
| Angulation | Straight | |||||
| Solid Cap | Description | The Solid Cap is used for protecting a Solid Abutment after taking impression, and minimizing irritation to tongue and oral mucosa. | ||||
| Material | POM | |||||
| Dimension | Ø 5.7 x 6.5, 8.0, 9.5 mm | |||||
| (Diameter & Length) | ||||||
| Post Height | 4.0, 5.5, 7.0 mm | |||||
| Solid Post | ||||||
| Abutment | Description | The Solid Post Abutment is used in conjunction with fixture to provide support for final prosthesis, and used in cement retained restoration only. It is connected to the Fixture by its threaded part. | ||||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | |||||
| Dimension | Ø 4.9 x 9.5, 10.5, 11.0, 11.5, 12.0, 12.5, 13.0, 13.5, 14.5 mm | |||||
| (Diameter & Length) | ||||||
| Gingival (Cuff) Height | 1.0, 2.0, 3.0 mm | |||||
| Post Height | 4.0, 5.5, 7.0 mm | |||||
| Angulation | Straight | |||||
| Solid Post | ||||||
| Cap | Description | The Solid Post Cap is used for protecting a Solid Post Abutment after taking impression, and minimizing irritation to tongue and oral mucosa. | ||||
| Material | POM | |||||
| Dimension | Ø 5.3 x 6.5, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0, 10.5, 11.5 mm | |||||
| (Diameter & Length) | ||||||
| Gingival (Cuff) Height | 1.0, 2.0, 3.0 mm | |||||
| Post Height | 4.0, 5.5, 7.0 mm | |||||
| Octa | ||||||
| Abutment | Description | The Octa Abutment is used in conjunction with fixture for fabricating screw-retained prosthesis. It is connected to the Fixture by its threaded part. | ||||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | |||||
| Dimension | Ø 3.5 x 6.5 mm | |||||
| (Diameter & Length) | ||||||
| Post Height | 1.5 mm | |||||
| Angulation | Straight | |||||
| Healing Cap | Description | The Healing Cap is used for protecting Octa Abutment and minimizing irritation to tongue and oral mucosa during period of gingival healing. It is connected to the Octa Abutment using Abutment Screw. | ||||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | |||||
| Dimension | Ø 5.2 x 4.0 mm | |||||
| (Diameter & Length) | ||||||
| Temporary | ||||||
| Cylinder | Description | The Temporary Cylinder is used in conjunction with Octa Abutment to provide support for provisional restoration. It is connected to the Octa Abutment using Abutment Screw. | ||||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | |||||
| Dimension | Ø 5.0 x 10.0 mm | |||||
| (Diameter & Length) | ||||||
| Post Heights | 7.0 mm | |||||
| Angulation | Straight | |||||
| EZ Post | ||||||
| Cylinder | Description | The EZ Post Cylinder is used in conjunction with Octa Abutment to provide support for cement and screw type final prosthesis. It is connected to the Octa Abutment using Abutment Screw. | ||||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | |||||
| Dimension | Ø 5.0 x 5.5, 7.0 mm | |||||
| (Diameter & Length) | ||||||
| Post Heights | 5.5, 7.0 mm | |||||
| Angulation | Straight | |||||
| Gold | Gold Cylinder | Description | The Gold Cylinder is used in conjunction with Octa Abutment | The Gold Cylinder is used in conjunction with Octa Abutment to provide support for screw type final prosthesis by casting with precious metal alloy (Gold alloy). It is connected to the Octa Abutment using Abutment Screw. | ||
| Material | Body: Gold Alloy / Sleeve: POM | |||||
| Dimension | ||||||
| (Diameter & Length) | $Ø$ 5.1 x 12.0 mm | |||||
| Post Heights | 10.0 mm | |||||
| Angulation | Straight | |||||
| CCM Cylinder | Description | The CCM Cylinder is used in conjunction with Octa Abutment | ||||
| to provide support for screw type final prosthesis by casting | ||||||
| with non-precious metal alloy (Co-Cr-Mo alloy). It is | ||||||
| connected to the Octa Abutment using Abutment Screw. | ||||||
| Material | Body: Gold Alloy / Sleeve: POM | |||||
| Dimension | ||||||
| (Diameter & Length) | $Ø$ 5.1 x 12.0 mm | |||||
| Post Heights | 10.0 mm | |||||
| Angulation | Straight | |||||
| Abutment | ||||||
| Screw | Description | The Abutment Screw is used for connecting the Octa | ||||
| Abutment to the Healing Cap, Temporary Cylinder, EZ Post | ||||||
| Cylinder, Gold Cylinder or CCM Cylinder. | ||||||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | |||||
| Dimension | ||||||
| (Diameter & Length) | $Ø$ 2.5 x 4.85 mm | |||||
| 5. Overdenture | ||||||
| Prosthesis | Meg-Loc | |||||
| Abutment | Description | The Meg-Loc Abutment is used in conjunction with fixture | ||||
| and intended to be connected to an overdenture to allow its | ||||||
| insertion and removal with its attachment (K151789). It is | ||||||
| connected to the Fixture using its threaded part. | ||||||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | |||||
| Dimension | ||||||
| (Diameter & Length) | $Ø$ 3.89 x 7.45, 7.95, 8.95, 9.95, 10.95, 11.95, 12.95, 13.95 mm | |||||
| Gingival (Cuff) Height | 0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8, 6.8 mm | |||||
| Post Height | 1.5 mm | |||||
| Angulation | Up to 20° | |||||
| Meg-Ball | ||||||
| Abutment | Description | The Meg-Ball Abutment is used in conjunction with fixture | ||||
| and intended to be connected to an overdenture to allow its | ||||||
| insertion and removal with its attachment (K192614). It is | ||||||
| connected to the Fixture using its threaded part. | ||||||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | |||||
| Dimension | ||||||
| (Head Diameter & | ||||||
| Head Length) | $Ø$ 2.25 x 4.15 mm | |||||
| Dimension | ||||||
| (Diameter & Length) | $Ø$ 3.5 x 10.1, 10.6, 11.6, 12.6, 13.6, 14.6, 15.6, 16.6 mm | |||||
| Gingival (Cuff) Height | 0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8, 6.8 mm | |||||
| Post Height | 4.15 mm | |||||
| Angulation | Up to 15° | |||||
| Meg- | ||||||
| Magnet | ||||||
| Abutment | Description | The Meg-Magnet Abutment is used in conjunction with | ||||
| fixture and intended to be connected to an overdenture to | ||||||
| allow its insertion and removal using the magnetic force of | ||||||
| magnet attachment. It is connected to the Fixture using its | ||||||
| threaded part. | ||||||
| Material | Stainless Steel (ASTM F899-20) | |||||
| Dimension | ||||||
| (Diameter & Length) | $Ø$ 4.5 x 6.20, 6.25, 6.75, 7.20, 7.75, 8.20, 8.75, 9.20, 9.75, | |||||
| 10.20, 10.75, 11.20, 11.75, 12.20, 12.75 mm | ||||||
| $Ø$ 5.0 x 6.20, 6.25, 6.75, 7.20, 7.75, 8.20, 8.75, 9.20, 9.75, | ||||||
| 10.20, 10.75, 11.20, 11.75, 12.20, 12.75 mm | ||||||
| Gingival (Cuff) Height | 0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8, 6.8 mm | |||||
| Angulation | Straight | |||||
| Meg- | ||||||
| Magnet | ||||||
| Abutment | Magnet | Dimension | ||||
| (Diameter & Length) | Description | $Ø$ 3.5 x 10.1, 10.6, 11.6, 12.6, 13.6, 14.6, 15.6, 16.6 mm | The Magnet is used in fixed overdenture restorations and | |||
| applied with Meg-Magnet Abutment to stabilize the | ||||||
| overdenture using its magnetic force. | ||||||
| Gingival (Cuff) Height | 0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8, 6.8 mm | |||||
| Post Height | 4.15 mm | |||||
| Angulation | Up to 15° | |||||
| Description | The Meg-Magnet Abutment is used in conjunction with | |||||
| fixture and intended to be connected to an overdenture to | ||||||
| allow its insertion and removal using the magnetic force of | ||||||
| magnet attachment. It is connected to the Fixture using its | ||||||
| threaded part. | ||||||
| Material | Stainless Steel (ASTM F899-20) | |||||
| Magnet | Dimension | |||||
| (Diameter & Length) | $Ø$ 4.5 x 6.20, 6.25, 6.75, 7.20, 7.75, 8.20, 8.75, 9.20, 9.75, | |||||
| 10.20, 10.75, 11.20, 11.75, 12.20, 12.75 mm | ||||||
| $Ø$ 5.0 x 6.20, 6.25, 6.75, 7.20, 7.75, 8.20, 8.75, 9.20, 9.75, | ||||||
| 10.20, 10.75, 11.20, 11.75, 12.20, 12.75 mm | ||||||
| Gingival (Cuff) Height | 0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8, 6.8 mm | |||||
| Angulation | Straight | |||||
| Description | The Magnet is used in fixed overdenture restorations and | |||||
| applied with Meg-Magnet Abutment to stabilize the | ||||||
| overdenture using its magnetic force. | ||||||
| Material | Stainless Steel (ASTM F899-20) | |||||
| Meg-Rhein | ||||||
| Abutment | Dimension | |||||
| (Diameter & Length) | $Ø$ 4.5 x 2.2 mm | |||||
| $Ø$ 5.0 x 2.2 mm | ||||||
| Description | The Meg-Rhein Abutment is used in conjunction with fixture | |||||
| and intended to be connected to an overdenture to allow its | ||||||
| insertion and removal with its attachment (K171409). It is | ||||||
| connected to the Fixture using its threaded part. | ||||||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | |||||
| Dimension | ||||||
| (Diameter & Length) | $Ø$ 3.5 x 7.45, 9.15, 11.15, 13.15 mm | |||||
| Gingival (Cuff) Height | 0.3, 2.0, 4.0, 6.0mm | |||||
| Post Height | 1.7 mm | |||||
| Angulation | Straight |
7
8
| Changes are explained not affecting substantial equivalence in this 510(k) Submission. | ||||||
|---|---|---|---|---|---|---|
| Predicate Device | Subject Device | |||||
| No. | 510(k) No. | Product Name | Material | Product Name | Material | Change |
| 1 | K052369 | Closing Screw | CP Ti Grade 3 | Closing Screw | Ti-6Al-4V ELI | - Material |
| 2 | K052369 | Cover Screw | CP Ti Grade 3 | Cover Screw | Ti-6Al-4V ELI | - Material |
| 3 | K052369 | Healing Abutment | CP Ti Grade 3 | Healing Abutment | Ti-6Al-4V ELI | - Material |
| 4 | K052369 | ExFeel Internal Multi-mount | CP Ti Grade 3 | Multi Post | Ti-6Al-4V ELI | - Product Name |
- Material |
| 5 | K052369 | ExFeel Internal Multi-mount Cap | No Change | Multi Post Cap | No Change | - Product Name |
| 6 | K052369 | ExFeel Internal Screw | No Change | Multi Post Screw | No Change | - Product Name |
| 7 | K052369 | Solid Abutment | CP Ti Grade 3 | Solid Abutment | Ti-6Al-4V ELI | - Material |
| 8 | K052369 | Solid Protect Cap | No Change | Solid Cap | No Change | - Product Name |
| 9 | K123988 | Octa Healing Cap | No Change | Healing Cap | No Change | - Product Name |
| 10 | K123988 | Temporary Cylinder | CP Ti Grade 4 | Temporary Cylinder | Ti-6Al-4V ELI | - Material |
| 11 | K123988 | EZ Post Cylinder | CP Ti Grade 4 | EZ Post Cylinder | Ti-6Al-4V ELI | - Material |
[Note. 1] Some of devices described in this submission had been FDA cleared with K052369 and it is being submitted to change their identifier with modification of product name or material as followings. The od not affecting substantial equivalence in this 510(k) Submis cha : ﻣﺎﻟﻤ
[Note. 2] Some of overdenture prosthesis described in this submission had been FDA cleared with K192614, but it is being submitted to change their identifier with modification of surface treatment or compatible implant system as followings. The changes are explained not affecting substantial equivalence in this 510(k) Submission.
Abutment Screw
No Change
- Product Name
No Change
Octa Abutment
Screw
12
| No. | Predicate Device | Subject Device | ||||||
|---|---|---|---|---|---|---|---|---|
| 510(k) | ||||||||
| No. | Product | |||||||
| Name | Surface | |||||||
| Treatment | Implant | |||||||
| System | Product | |||||||
| Name | Surface | |||||||
| Treatment | Implant | |||||||
| System | Change | |||||||
| 1 | K192614 | Meg-Loc | ||||||
| Abutment | Machined | ExFeel | ||||||
| Dental | ||||||||
| Implant | ||||||||
| System | ||||||||
| (K052369) | Meg-Loc | |||||||
| Abutment | TiN | |||||||
| Coating | AnyOne | |||||||
| Onestage | ||||||||
| Implant | ||||||||
| System | - Surface Treatment |
- Implant System |
| 2 | K192614 | Meg-Ball
Abutment | No
Change | ExFeel
Dental
Implant
System
(K052369) | Meg-Ball
Abutment | No
Change | AnyOne
Onestage
Implant
System | - Implant System |
| 3 | K192614 | Meg-
Magnet
Abutment | No
Change | ExFeel
Dental
Implant
System
(K052369) | Meg-
Magnet
Abutment | No
Change | AnyOne
Onestage
Implant
System | - Implant System |
9
6. Indication for use
The AnyOne Onestage Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:
-Delayed loading.
-Immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region.
7. Basis for Substantial Equivalence
The AnyOne Onestage Implant System is substantially equivalent to the predicate devices in terms of indication for use, technical characteristic and function. They are made of the same material and have similar design.
The Indications for Use for the subject devices is identical to the primary predicate, K182448.
In order to demonstrate the difference in design does not raise any new issues, the performance test on the subject and predicate device have been performed in consideration of the worst case according to 'ISO 14801' and 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment' to figure out the physical property. The test result supports the substantial equivalence to the predicate devices.
Based on the comparison charts below and test results provided in this submission, we conclude that the subject device is substantially equivalent to the predicate devices.
10
AnyOne Onestage Fixture
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K210161 | K182448 | K052369 |
| Device Name | |||
| (Compatible | |||
| Implant | |||
| System) | AnyOne Onestage Fixture | ||
| For AnyOne Onestage Implant | |||
| System | AnyRidge Octa 1 Fixture | ||
| For AnyRidge Octa 1 Implant | |||
| System | ExFeel Internal Fixture | ||
| For ExFeel Dental Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | |||
| Use Statement | The AnyOne Onestage Implant | ||
| System is intended to be | |||
| surgically placed in the maxillary | |||
| or mandibular arches for the | |||
| purpose of providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used | |||
| to restore a patient's chewing | |||
| function in the following | |||
| situations and with the clinical | |||
| protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal loading. | |||
| Larger implants are dedicated for | |||
| the molar region. | The AnyRidge Octa 1 Implant | ||
| System is intended to be | |||
| surgically placed in the maxillary | |||
| or mandibular arches for the | |||
| purpose of providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used | |||
| to restore a patient's chewing | |||
| function in the following | |||
| situations and with the clinical | |||
| protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal loading. | |||
| Larger implants are dedicated for | |||
| the molar region. | The ExFeel Dental Implant | ||
| Systems are intended to be | |||
| placed in the upper or lower jaw | |||
| to support prosthetic devices, | |||
| such as artificial teeth, and to | |||
| restore a patient's chewing | |||
| function. This may be | |||
| accomplished using either a two | |||
| stage surgical procedure or a | |||
| single stage surgical procedure. | |||
| Design | Image: AnyOne Onestage Fixture | Image: AnyRidge Octa 1 Fixture | Image: ExFeel Internal Fixture |
| Diameter (Ø) | 3.9, 4.3, 4.8, 5.3 mm | 3.6, 4.0, 4.4, 4.7, 4.8, 5.0, | |
| 5.5mm | 3.5, 4.1, 4.8 mm | ||
| Length | 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 | ||
| mm | 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, | ||
| 17.2mm | 7.0, 8.5, 10.0, 11.5, 13.0 mm | ||
| Gingival (Cuff) | |||
| Height | 1.2, 1.8, 2.2 mm | N/A | 2.2 mm |
| Implant-to | |||
| Abutment | |||
| Connection | Internal Octa | Internal Octa | Internal Octa |
| Material | CP Ti Grade 4 (ASTM F67-13) | CP Ti Grade 4 (ASTM F67-13) | CP Ti Grade 4 (ASTM F67-13) |
| Single Use | Yes | Yes | Yes |
| Surface | |||
| Treatment | Sand-blasted, Large grit, Acid- | ||
| etched (SLA) and | |||
| Partial Anodizing in upper part | Sand-blasted, Large grit, Acid- | ||
| etched (SLA) | Sand-blasted (RBM) and | ||
| Partial Anodizing in upper part | |||
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Shelf Life | 5 years | 5 years | 5 years |
| Feature | - Straight / Tapered body shape |
- cutting edge with self-tapping
- 0.8mm thread pitch | - Straight / Tapered body shape
- cutting edge with self-tapping
- 0.8mm thread pitch | - Straight / Root form shape
- cutting edge with self-tapping
- 1.25mm thread pitch |
| Principle of
Operation | It is a tapered body fixture which
is inserted in the alveolar bone. It
replaces the functions of the
missing teeth as a dental implant
fixture. | It is a tapered body fixture which
is inserted in the alveolar bone. It
replaces the functions of the
missing teeth as a dental implant
fixture. | It is a root form fixture which is
inserted in the alveolar bone. It
replaces the functions of the
missing teeth as a dental implant
fixture. |
1. Similarities
The subject device has the same characteristic for the followings compared to the predicate device.
Indication for use, Design, Connection, Material, Single Use, Sterilization, Shelf Life, Feature and Principle of Operation.
2. Differences
The subject device has the different characteristic for the followings compared to the predicate device.
Diameter & Length ।
The Diameter and Length of subject device is slightly different with predicate device but all the dimensions of subject device lie within the range of predicate device and reference device.
-Gingival (Cuff) Height
The subject device has cuff height with consideration for soft tissue level while the predicate device is not applicable but the reference device has a cuff height. Also, the total length of subject device including the cuff height lie within the range of predicate device and reference device, and it does not cause a matter in substantial equivalence since
11
the size of cuff height is very minor, the cuff height provides good gingival adaptation and the variety of the size can be possible to operate more precise treatment to meet each patient's condition.
. Surface Treatment
The general surface treatment of subject device is same as predicate device with SLA method, but the subject device is additionally treated with anodizing in upper part for good visibility of cuff height. The substantially equivalent can be explained with reference device which has same surface treatment for anodizing.
3. Discussion
The proposed AnyOne Onestage Fixture and predicate device have common in all the items in the comparison chart except the Diameter, Length, Giff) Height and Surface Treatment. These differences are explained not affecting on the substantial equivalence, but the fatigue test was performed on the subject device and predicate device to confirm the substantial equivalence, with combination of the worst case design fixture and abutment, according to "ISO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment". The test result supports that the subject device is substantially equivalent to the predicate device and the differences are not affecting the substantial equivalence. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device.
12
Closing Screw
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K210161 | K182448 | K052369 |
| Device Name | |||
| (Compatible | |||
| Implant | |||
| System) | Closing Screw | ||
| For AnyOne Onestage Implant | |||
| System | Cover Screw | ||
| For AnyRidge Octa 1 Implant System | Closing Screw | ||
| For ExFeel Dental Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | |||
| Use Statement | The AnyOne Onestage Implant | ||
| System is intended to be | |||
| surgically placed in the maxillary | |||
| or mandibular arches for the | |||
| purpose of providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used | |||
| to restore a patient's chewing | |||
| function in the following | |||
| situations and with the clinical | |||
| protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal | |||
| loading. Larger implants are | |||
| dedicated for the molar region. | The AnyRidge Octa 1 Implant | ||
| System is intended to be | |||
| surgically placed in the maxillary | |||
| or mandibular arches for the | |||
| purpose of providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used | |||
| to restore a patient's chewing | |||
| function in the following | |||
| situations and with the clinical | |||
| protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal | |||
| loading. Larger implants are | |||
| dedicated for the molar region. | The ExFeel Dental Implant | ||
| Systems are intended to be | |||
| placed in the upper or lower jaw | |||
| to support prosthetic devices, | |||
| such as artificial teeth, and to | |||
| restore a patient's chewing | |||
| function. This may be | |||
| accomplished using either a two | |||
| stage surgical procedure or a | |||
| single stage surgical procedure. | |||
| Design | Image: Closing Screw | Image: Cover Screw | Image: Closing Screw |
| Diameter (Ø) | 3.5 mm | 3.0, 3.7, 5.0, 6.0 mm | 3.5 mm |
| Total Length | 6.0 mm | 6.6, 7.1 mm | 6.0 mm |
| Gingival (Cuff) | |||
| Height | 1.5 mm | 0.5, 1.0 mm | 1.5 mm |
| Angulation | Straight | Straight | Straight |
| Connection | |||
| Interface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection |
| Material | Ti-6Al-4V ELI | ||
| (ASTM F136-13) | Ti-6Al-4V ELI | ||
| (ASTM F136-13) | CP Ti Grade 3 | ||
| (ASTM F67-13) | |||
| Surface | |||
| Treatment | Machined | Anodizing | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Principle of | |||
| Operation | The Closing Screw is used for | ||
| protecting the inner structure of | |||
| a fixture, and exposed fixture | |||
| platform after fixture placement. | The Cover Screw is used for | ||
| protecting the inner structure of | |||
| a fixture, and exposed fixture | |||
| platform after fixture placement. | The Closing Screw is used for | ||
| protecting the inner structure of | |||
| a fixture, and exposed fixture | |||
| platform after fixture placement. | |||
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the reference device.
Indication for use, Design, Diameter, Total Length, Gingival Height, Angulation, Connection Interface, Surface -Treatment, Single Use, Sterilization and Principle of Operation
2. Differences
The subject device has the different characteristic for the followings compared to the reference device.
Material -The subject device is made of titanium alloy while the reference device is made entirely of commercially pure titanium, but has made with same material with predicate device. Also, the multiple predicate & reference devices for titanium alloy are presented in the other component comparison charts.
- Discussion
The proposed Closing Screw had been FDA cleared with K052639, but it is being submitted to change their identifier with modification of material. Therefore, the proposed Closing Screw and reference device have common in all the items in the comparison chart except the material difference is explained not affecting on the substantial equivalence. Also, these devices were not tested for fatigue strength as they are not placed into occlusion. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device.
13
Cover Screw
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K210161 | K182448 | K052369 |
| Device Name | |||
| (Compatible | |||
| Implant | |||
| System) | Cover Screw | ||
| For AnyOne Onestage Implant | |||
| System | Cover Screw | ||
| For AnyRidge Octa 1 Implant System | Cover Screw | ||
| For ExFeel Dental Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | |||
| Use Statement | The AnyOne Onestage Implant | ||
| System is intended to be | |||
| surgically placed in the maxillary | |||
| or mandibular arches for the | |||
| purpose of providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used | |||
| to restore a patient's chewing | |||
| function in the following | |||
| situations and with the clinical | |||
| protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal | |||
| loading. Larger implants are | |||
| dedicated for the molar region. | The AnyRidge Octa 1 Implant | ||
| System is intended to be | |||
| surgically placed in the maxillary | |||
| or mandibular arches for the | |||
| purpose of providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used | |||
| to restore a patient's chewing | |||
| function in the following | |||
| situations and with the clinical | |||
| protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal | |||
| loading. Larger implants are | |||
| dedicated for the molar region. | The ExFeel Dental Implant Systems | ||
| are intended to be placed in the | |||
| upper or lower jaw to support | |||
| prosthetic devices, such as artificial | |||
| teeth, and to restore a patient's | |||
| chewing function. This may be | |||
| accomplished using either a two | |||
| stage surgical procedure or a single | |||
| stage surgical procedure. | |||
| Design | Image: Subject Device Screw | Image: Primary Predicate Device Screw | Image: Reference Device Screw |
| Diameter (Ø) | 4.85 mm | 3.0, 3.7, 5.0, 6.0 mm | 4.85 mm |
| Total Length | 7.0 mm | 6.6, 7.1 mm | 7.0 mm |
| Gingival (Cuff) | |||
| Height | 1.5 mm | 0.5, 1.0 mm | 1.5 mm |
| Angulation | Straight | Straight | Straight |
| Connection | |||
| Interface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection |
| Material | Ti-6Al-4V ELI | ||
| (ASTM F136-13) | Ti-6Al-4V ELI | ||
| (ASTM F136-13) | CP Ti Grade 3 | ||
| (ASTM F67-13) | |||
| Surface | |||
| Treatment | Machined | Anodizing | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Principle of | |||
| Operation | The Cover Screw is used for | ||
| protecting the inner structure of | |||
| a fixture, and exposed fixture | |||
| platform after fixture placement. | The Cover Screw is used for | ||
| protecting the inner structure of | |||
| a fixture, and exposed fixture | |||
| platform after fixture placement. | The Cover Screw is used for | ||
| protecting the inner structure of | |||
| a fixture, and exposed fixture | |||
| platform after fixture placement. | |||
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the reference device.
Indication for use, Design, Diameter, Total Length, Gingival Height, Angulation, Connection Interface, Surface -Treatment, Single Use, Sterilization and Principle of Operation
2. Differences
The subject device has the different characteristic for the followings compared to the reference device.
Material -The subject device is made of titanium alloy while the reference device is made entirely of commercially pure titanium, but has made with same material with predicate device. Also, the multiple predicate & reference devices for titanium alloy are presented in the other component comparison charts.
- Discussion
The proposed Cover Screw had been FDA cleared with K052639, but it is being submitted to change their identifier with modification of material. Therefore, the proposed Cover Screw and reference device have common in all the items in the comparison chart except the material difference is explained not affecting on the substantial equivalence. Also, these devices were not tested for fatigue strength as they are not placed into occlusion. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device.
14
Healing Abutment
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K210161 | K182448 | K052369 |
| Device Name | |||
| (Compatible | |||
| Implant | |||
| System) | Healing Abutment | ||
| For AnyOne Onestage Implant | |||
| System | Healing Abutment | ||
| For AnyRidge Octa 1 Implant System | Healing Abutment | ||
| For ExFeel Dental Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | |||
| Use Statement | The AnyOne Onestage Implant | ||
| System is intended to be | |||
| surgically placed in the maxillary | |||
| or mandibular arches for the | |||
| purpose of providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used | |||
| to restore a patient's chewing | |||
| function in the following | |||
| situations and with the clinical | |||
| protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal | |||
| loading. Larger implants are | |||
| dedicated for the molar region. | The AnyRidge Octa 1 Implant | ||
| System is intended to be | |||
| surgically placed in the maxillary | |||
| or mandibular arches for the | |||
| purpose of providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used | |||
| to restore a patient's chewing | |||
| function in the following | |||
| situations and with the clinical | |||
| protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal | |||
| loading. Larger implants are | |||
| dedicated for the molar region. | The ExFeel Dental Implant | ||
| Systems are intended to be | |||
| placed in the upper or lower jaw | |||
| to support prosthetic devices, | |||
| such as artificial teeth, and to | |||
| restore a patient's chewing | |||
| function. This may be | |||
| accomplished using either a two | |||
| stage surgical procedure or a | |||
| single stage surgical procedure. | |||
| Design | Image: Design of subject device | Image: Design of primary predicate device | Image: Design of reference device |
| Diameter (Ø) | 5.5 mm | 3.2, 4.2, 5.2, 6.2 mm | 5.5 mm |
| Total Length | 6.5, 7.5, 8.5 mm | 8.6, 9.6, 10.6, 11.6, 12.6, 13.6, | |
| 14.6, 15.6 mm | 6.5, 7.5, 8.5 mm | ||
| Gingival (Cuff) | |||
| Height | 2.0, 3.0, 4.0 mm | 2.5, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5, | |
| 9.5 mm | 2.0, 3.0, 4.0 mm | ||
| Angulation | Straight | Straight | Straight |
| Connection | |||
| Interface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection |
| Material | Ti-6Al-4V ELI | ||
| (ASTM F136-13) | Ti-6Al-4V ELI | ||
| (ASTM F136-13) | CP Ti Grade 3 | ||
| (ASTM F67-13) | |||
| Surface | |||
| Treatment | Machined | Anodizing | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Principle of | |||
| Operation | The Healing Abutment is | ||
| fastened into the female screw | |||
| of dental implant and support | |||
| the gingival shaping. | The Healing Abutment is | ||
| fastened into the female screw | |||
| of dental implant and support | |||
| the gingival shaping. | The Healing Abutment is | ||
| fastened into the female screw | |||
| of dental implant and support | |||
| the gingival shaping. | |||
| Substantial Equivalence Discussion | |||
| 1. | |||
| Similarities | |||
| Subject Device | Primary Predicate Device | Reference Device | |
| 510(k) No. | K210161 | K182448 | K052369 |
| Device Name | |||
| (Compatible | |||
| Implant | |||
| System) | Multi Post | ||
| For AnyOne Onestage Implant | |||
| System | EZ Post Abutment | ||
| For AnyRidge Octa 1 Implant System | ExFeel Internal Multi-mount | ||
| For ExFeel Dental Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | |||
| Use Statement | The AnyOne Onestage Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or mandibular | |||
| arches for the purpose of providing | |||
| prosthetic support for dental | |||
| restorations (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used to | |||
| restore a patient's chewing function | |||
| in the following situations and with | |||
| the clinical protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and with | |||
| appropriate occlusal loading. Larger | |||
| implants are dedicated for the molar | |||
| region. | The AnyRidge Octa 1 Implant System | ||
| is intended to be surgically placed in | |||
| the maxillary or mandibular arches | |||
| for the purpose of providing | |||
| prosthetic support for dental | |||
| restorations (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used to | |||
| restore a patient's chewing function | |||
| in the following situations and with | |||
| the clinical protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and with | |||
| appropriate occlusal loading. Larger | |||
| implants are dedicated for the molar | |||
| region. | The ExFeel Dental Implant Systems | ||
| are intended to be placed in the | |||
| upper or lower jaw to support | |||
| prosthetic devices, such as artificial | |||
| teeth, and to restore a patient's | |||
| chewing function. This may be | |||
| accomplished using either a two | |||
| stage surgical procedure or a single | |||
| stage surgical procedure. | |||
| Design | |||
| Diameter (Ø) | 5.5 mm | 4.0, 5.0, 6.0, 7.0 mm | 5.5 mm |
| Total Length | 8.7 mm | 7.85 - 16.35 mm | 8.7 mm |
| Gingival (Cuff) | |||
| Height | 1.0 mm | 0.8, 1.8, 2.8, 3.8, 4.8 mm | 1.0 mm |
| Post Height | 5.5 mm | 4.0, 5.5, 7.0 mm | 5.5 mm |
| Angulation | Straight | Straight | Straight |
| Connection | |||
| Interface | Internal Octa | Internal Octa, Internal Non-Octa | Internal Octa |
| Material | Ti-6Al-4V ELI | ||
| (ASTM F136-13) | Ti-6Al-4V ELI | ||
| (ASTM F136-13) | CP Ti Grade 3 | ||
| (ASTM F67-13) | |||
| Surface | |||
| Treatment | Anodizing | Anodizing | Anodizing |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle of | |||
| Operation | The Multi Post is a | ||
| superstructure which is | |||
| connected to the Fixtures using | |||
| the Multi Post Screw. It replaces | |||
| the functions of the missing | |||
| teeth as a dental abutment. | The EZ Post Abutment is a | ||
| superstructure which is | |||
| connected to the Fixtures using | |||
| the Abutment Screw. It replaces | |||
| the functions of the missing | |||
| teeth as a dental abutment. | The ExFeel Internal Multi-mount | ||
| is a superstructure which is | |||
| connected to the Fixtures using | |||
| the ExFeel Internal Screw. It | |||
| replaces the functions of the | |||
| missing teeth as a dental | |||
| abutment. | |||
| Substantial Equivalence Discussion | |||
| 1. Similarities | |||
| The subject device has the same characteristic for the followings compared to the reference device. | |||
| Indication for use, Design, Diameter, Total Length, Gingival Height, Post Height, Angulation, Connection Interface, | |||
| Surface Treatment, Single Use, Sterilization and Principle of Operation | |||
| 2. Differences | |||
| The subject device has the different characteristic for the followings compared to the reference device. | |||
| Material | |||
| The subject device is made of titanium alloy while the reference device is made entirely of commercially pure | |||
| titanium, but has made with same material with predicate device. Also, the multiple predicate & reference devices | |||
| for titanium alloy are presented in the other component comparison charts. | |||
| 3. Discussion | |||
| The proposed Multi Post had been FDA cleared under K052639 with product name of 'ExFeel Internal Multi- | |||
| mount' but it is being submitted to change their identifier with modification of product name and material. | |||
| Subject Device | Reference Device | ||
| 510(k) No. | K210161 | K052369 | |
| Device Name | |||
| (Compatible | |||
| Implant System) | Multi Post Cap | ||
| For AnyOne Onestage Implant System | ExFeel Internal Multi-mount Cap | ||
| For ExFeel Dental Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | |
| Indications for | |||
| Use Statement | The AnyOne Onestage Implant System is intended | ||
| to be surgically placed in the maxillary or | |||
| mandibular arches for the purpose of providing | |||
| prosthetic support for dental restorations (Crown, | |||
| bridges, and overdentures) in partially or fully | |||
| edentulous individuals. It is used to restore a | |||
| patient's chewing function in the following | |||
| situations and with the clinical protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and with appropriate | |||
| occlusal loading. Larger implants are dedicated for | |||
| the molar region. | The ExFeel Dental Implant Systems are intended to be | ||
| placed in the upper or lower jaw to support prosthetic | |||
| devices, such as artificial teeth, and to restore a patient's | |||
| chewing function. This may be accomplished using either | |||
| a two stage surgical procedure or a single stage surgical | |||
| procedure. | |||
| Design | Image: Design of Multi Post Cap | Image: Design of ExFeel Internal Multi-mount Cap | |
| Diameter (Ø) | 5.9 mm | 5.9 mm | |
| Total Length | 6.5 mm | 6.5 mm | |
| Post Height | 5.5 mm | 5.5 mm | |
| Material | POM | POM | |
| Surface | |||
| Treatment | N/A | N/A | |
| Single Use | Yes | Yes | |
| Sterilization | Non-sterile | Non-sterile | |
| Principle of | |||
| Operation | The multi post cap is used to relieve feeling of | ||
| irritation and protect until the prosthesis is | |||
| produced after the impression is taken. | The multi post cap is used to relieve feeling of | ||
| irritation and protect until the prosthesis is | |||
| produced after the impression is taken. | |||
| Substantial Equivalence Discussion |
ice has the same characteristic for the followings compared to the reference de sublect dei
Indication for use, Design, Diameter, Total Length, Gingival Height, Angulation, Connection Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation
2. Differences
The subject device has the different characteristic for the followings compared to the reference device.
Material -
The subject device is made of titanium alloy while the reference device is made entirely of commercially pure titanium, but has made with same material with predicate device. Also, the multiple predicate & reference devices for titanium alloy are presented in the other component comparison charts.
- Discussion
The proposed Healing Abutment had been FDA cleared with K052639, but it is being submitted to change their identifier with modification of material. Therefore, the proposed Healing Abutment and reference device have common in all the items in the comparison chart except the material difference is explained not affecting on the substantial equivalence. Also, these devices were not tested for fatigue strength as they are not placed into occlusion. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device.
15
Multi Post
Therefore, the proposed Multi Post and reference device have common in all the items in the comparison chart except the material. The material difference is explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is a straight type. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device.
16
Multi Post Cap
Similarities T.
The subject device has the same characteristic for the followings compared to the reference device.
Indication for use, Design, Diameter, Total Length, Post Height, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation.
Differences 2.
- N/A
3. Discussion
The proposed Multi Post Cap had been FDA cleared under K052639 with product name of 'ExFeel Internal Multi-mount Cap', but it is being submitted to change their identifier with modification of product name only. Therefore, the proposed Multi Post Cap and reference device have common in all the items in the comparison chart. Also, these devices were not tested for fatigue strength as they are not placed into occlusion. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference device.
17
EZ Post Abutment
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K210161 | K182448 | K052369 |
| Device Name | |||
| (Compatible | |||
| Implant System) | EZ Post Abutment | ||
| For AnyOne Onestage Implant | |||
| System | EZ Post Abutment | ||
| For AnyRidge Octa 1 Implant | |||
| System | Solid Abutment | ||
| For ExFeel Dental Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | |||
| Use Statement | The AnyOne Onestage Implant | ||
| System is intended to be | |||
| surgically placed in the maxillary | |||
| or mandibular arches for the | |||
| purpose of providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and | |||
| overdentures) in partially or | |||
| fully edentulous individuals. It is | |||
| used to restore a patient's | |||
| chewing function in the | |||
| following situations and with | |||
| the clinical protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal | |||
| loading. Larger implants are | |||
| dedicated for the molar region. | The AnyRidge Octa 1 Implant | ||
| System is intended to be | |||
| surgically placed in the maxillary | |||
| or mandibular arches for the | |||
| purpose of providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and | |||
| overdentures) in partially or | |||
| fully edentulous individuals. It is | |||
| used to restore a patient's | |||
| chewing function in the | |||
| following situations and with | |||
| the clinical protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal | |||
| loading. Larger implants are | |||
| dedicated for the molar region. | The ExFeel Dental Implant Systems | ||
| are intended to be placed in the | |||
| upper or lower jaw to support | |||
| prosthetic devices, such as artificial | |||
| teeth, and to restore a patient's | |||
| chewing function. This may be | |||
| accomplished using either a two | |||
| stage surgical procedure or a single | |||
| stage surgical procedure. | |||
| Design | Image: Design of EZ Post Abutment | Image: Design of EZ Post Abutment | Image: Design of Solid Abutment |
| Diameter (Ø) | 4.8 mm | 4.0, 5.0, 6.0, 7.0 mm | 3.5 mm |
| Total Length | 6.2, 7.2, 7.7, 8.2, 8.7, 9.2, 9.7, | ||
| 10.2, 10.7, 11.2, 12.2 mm | 7.85, 8.85, 9.35, 9.85, 10.35, | ||
| 10.85, 11.35, 11.85, 12.35, | |||
| 12.85, 13.35, 13.85, 14.35, | |||
| 14.85, 15.35, 16.35 mm | 9.0, 10.5, 12.0 mm | ||
| Gingival (Cuff) | |||
| Height | 0.0, 1.0, 2.0, 3.0 mm | 1.0, 2.0, 3.0, 4.0, 5.0 mm | 0.0 mm |
| Post Height | 4.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm |
| Angulation | Straight | Straight | Straight |
| Connection | |||
| Interface | Internal Octa, Internal Non- | ||
| Octa | Internal Octa, Internal Non- | ||
| Octa | Internal Conical Connection | ||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | CP Ti Grade 3 (ASTM F67-13) |
| Surface | |||
| Treatment | Anodizing | Anodizing | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle of | |||
| Operation | The EZ Post Abutment is a | ||
| superstructure which is | |||
| connected to the Fixtures using | |||
| the Multi Post Screw. It replaces | |||
| the functions of the missing | |||
| teeth as a dental abutment. | The EZ Post Abutment is a | ||
| superstructure which is | |||
| connected to the Fixtures using | |||
| the Abutment Screw. It replaces | |||
| the functions of the missing | |||
| teeth as a dental abutment. | The Solid Abutment is a pre- | ||
| manufactured prosthetic | |||
| component connected to the | |||
| endosseous dental implant by | |||
| its threaded part for aid in | |||
| prosthetic rehabilitation. | |||
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the predicate device.
Indication for use, Design, Post Height, Angulation, Connection Interface, Material, Surface Treatment, Single Use, -Sterilization and Principle of Operation
2. Differences
The subject device has the different characteristic for the followings compared to the predicate device.
Diameter -
The diameter of subject device is slightly different with predicate device, but the Diameters of subject device lie within the range of predicate device.
-Total Length
The Length of subject device is slightly different with predicate device, but has same Gingival Height with predicate & reference devices. Also, it does not cause a matter in substantial equivalence since the size difference is very minor.
18
Gingival (Cuff) Height
The subject device includes the models do not have the cuff height (0.0mm) while the predicate device has cuff height from 1.0 mm to 5.0mm. However, the reference device is not applicable the cuff height as the subject device. The difference in cuff height is acceptable for the subject device as it is intended to be used with a tissue level implant, with a portion of the cuff height built into the implant, whereas the predicate device is intended to be used with a bone level implant which requires a cuff height for all abutments.
3. Discussion -
The proposed EZ Post Abutment is being submitted to add in Megagen's existing prosthetic portfolio which had been FDA cleared. Therefore, the proposed EZ Post Abutment and predicate device have common in all the items in the comparison chart except the Diameter and Total Length. The size differences are explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is straight type. On the basis of the discussion above, it is concluded that the substantially equivalent to the predicate device.
19
Angled Abutment
| Subject Device | Primary Predicate Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|---|
| 510(k) No. | K210161 | K182448 | K150537 | K182448 |
| Device Name | ||||
| (Compatible | ||||
| Implant | ||||
| System) | Angled Abutment | |||
| For AnyOne Onestage | ||||
| Implant System | Angled Abutment | |||
| For AnyRidge Octa 1 | ||||
| Implant System | Angled Abutment | |||
| For MiNi Internal Implant | ||||
| System | Multi-unit Angled | |||
| Abutment | ||||
| For AnyRidge Octa 1 | ||||
| Implant System | ||||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications | ||||
| for Use | ||||
| Statement | The AnyOne Onestage | |||
| Implant System is intended | ||||
| to be surgically placed in | ||||
| the maxillary or mandibular | ||||
| arches for the purpose of | ||||
| providing prosthetic | ||||
| support for dental | ||||
| restorations (Crown, | ||||
| bridges, and overdentures) | ||||
| in partially or fully | ||||
| edentulous individuals. It is | ||||
| used to restore a patient's | ||||
| chewing function in the | ||||
| following situations and | ||||
| with the clinical protocols: | ||||
| -Delayed loading. | ||||
| -Immediate loading when | ||||
| good | ||||
| primary stability is | ||||
| achieved and with | ||||
| appropriate occlusal | ||||
| loading. Larger implants | ||||
| are dedicated for the molar | ||||
| region. | The AnyRidge Octa 1 | |||
| Implant System is intended | ||||
| to be surgically placed in | ||||
| the maxillary or mandibular | ||||
| arches for the purpose of | ||||
| providing prosthetic | ||||
| support for dental | ||||
| restorations (Crown, | ||||
| bridges, and overdentures) | ||||
| in partially or fully | ||||
| edentulous individuals. It is | ||||
| used to restore a patient's | ||||
| chewing function in the | ||||
| following situations and | ||||
| with the clinical protocols: | ||||
| -Delayed loading. | ||||
| -Immediate loading when | ||||
| good | ||||
| primary stability is | ||||
| achieved and with | ||||
| appropriate occlusal | ||||
| loading. Larger implants | ||||
| are dedicated for the molar | ||||
| region. | The MiNi Internal Implant | |||
| System is intended for two- | ||||
| stage surgical procedures | ||||
| in the following situations | ||||
| and with the following | ||||
| clinical protocols: |
- The intended use for the
3.0 mm diameter MiNi
implant is limited to the
replacement of
maxillary lateral incisors
and mandibular incisors. - Immediate placement in
extraction sites and in
situations with a partially
or completely
healed alveolar ridge. - It is intended for delayed
loading. | The AnyRidge Octa 1
Implant System is intended
to be surgically placed in
the maxillary or mandibular
arches for the purpose of
providing prosthetic
support for dental
restorations (Crown,
bridges, and overdentures)
in partially or fully
edentulous individuals. It is
used to restore a patient's
chewing function in the
following situations and
with the clinical protocols:
-Delayed loading.
-Immediate loading when
good
primary stability is achieved
and with appropriate
occlusal loading. Larger
implants are dedicated for
the molar region. |
| Design | | | | |
| Diameter (Ø) | 3.7 mm | 4.0, 5.0, 6.0, 7.0mm | 3.5 mm | 4.8 mm |
| Total Length | 9.0 mm | 10.85, 11.85, 12.35,
12.85, 13.35, 13.85,
14.35, 14.85, 15.35,
16.35 mm | 11.7, 12.7, 13.7 mm | 6.8, 7.48, 7.8, 8.48, 8.5,
8.8, 8.98, 9.5, 9.98, 10.5
mm |
| Gingival
(Cuff) Height | N/A | 0.8, 1.8, 2.8, 3.8, 4.8mm | 2.5, 3.5, 4.5 mm | 2.3, 3.3, 4.3mm |
| Post Height | 6.5 mm | 7.0 mm | 7.0 mm | 2.2 mm |
| Angulation | 15°, 25° | 15°, 25° | 15° | 17°, 30° |
| Connection
Interface | Internal Octa | Internal Octa | Internal Hex | Internal Octa,
Internal Non-Octa |
| Material | Ti-6Al-4V ELI
(ASTM F136-13) | Ti-6Al-4V ELI
(ASTM F136-13) | Ti-6Al-4V ELI
(ASTM F136-13) | Ti-6Al-4V ELI
(ASTM F136-13) |
| Surface
Treatment | Anodizing | Anodizing, Machined | Anodizing | Anodizing |
| Single Use | Yes | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Principle of
Operation | The Angled Abutment is
a superstructure which
is connected to the
fixtures using the
Abutment Screw. It
replaces the functions
of the missing teeth as a
dental abutment. | The Angled Abutment is
a superstructure which
is connected to the
fixtures using the
Abutment Screw. It
replaces the functions
of the missing teeth as a
dental abutment. | The Angled Abutment is
a superstructure which
is connected to the
fixtures using the
Abutment Screw. It
replaces the functions
of the missing teeth as a
dental abutment. | The Multi-unit Angled
Abutment is a pre-
manufactured
prosthetic component
connected to the
endosseous dental
implant using the Multi-
unit Abutment screw for
aid in prosthetic
rehabilitation. |
- Similarities
The subject device has the same characteristic for the followings compared to the predicate device.
Indication for use, Design, Angulation, Connection Interface, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation
20
| 2. | Differences |
|---|---|
| The subject device has the different characteristic for the followings compared to the predicate device. | |
| - Diameter & Total Length | |
| The diameter and total length of subject device is slightly different with predicate device, but all the dimensions of | |
| subject device lie within combined range of predicate & reference devices. | |
| - Gingival (Cuff) Height & Post Height | |
| The subject device is not applicable the cuff height while the predicate device has the cuff height. That's why the | |
| total length of subject device is slightly shorter than predicate device. However, it can be replaced with Fixture's | |
| cuff height connecting the proposed fixture and angled abutment. | |
| The Post Height of subject device is slightly different with predicate device, but it lies within combined range of | |
| predicate & reference devices. | |
| The difference in cuff height is acceptable for the subject device as it is intended to be used with a tissue level | |
| implant, with a portion of the cuff height built into the implant, whereas the predicate device is intended to be used | |
| 3. | with a bone level implant which requires a cuff height for all abutments. |
| Discussion | |
| - The proposed Angled Abutment is being submitted to add in Megagen's existing prosthetic portfolio which had | |
| been FDA cleared as with predicate device. Therefore, the proposed Angled Abutment and predicate device have | |
| common in all the items in the comparison chart except the Diameter, Total Length, Gingival (Cuff) Height and Post | |
| Height. These size differences are explained not affecting on the substantial equivalence, but the fatigue test was | |
| performed on the subject & predicate devices to confirm the substantial equivalence. The subject device, Angled | |
| Abutment has been selected as the representative specimen in this submission under the consideration of worst | |
| case in accordance with 'ISO 14801' and 'Class II Special Controls Guidance Document: Root-form Endosseous | |
| Dental Implants and Endosseous Dental Implant Abutment'. The test result supports that the subject device is | |
| substantially equivalent to the predicate device and the differences are not affecting the substantial equivalence. | |
| On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the | |
| predicate device. | |
21
Gold Abutment
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) No. | K210161 | K123988 | K123988 |
| Device Name | |||
| (Compatible | |||
| Implant System) | Gold Abutment | ||
| For AnyOne Onestage Implant | |||
| System | Gold Abutment | ||
| For AnyOne Internal Implant | |||
| System | Gold Cylinder | ||
| For AnyOne Internal Implant | |||
| System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for Use | |||
| Statement | The AnyOne Onestage Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or | |||
| mandibular arches for the purpose | |||
| of providing prosthetic support for | |||
| dental restorations (Crown, bridges, | |||
| and overdentures) in partially or | |||
| fully edentulous individuals. It is | |||
| used to restore a patient's chewing | |||
| function in the following situations | |||
| and with the clinical protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal loading. | |||
| Larger implants are dedicated for | |||
| the molar region. | The AnyOne Internal Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or | |||
| mandibular molar areas for the | |||
| purpose providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and overdentures) | |||
| in partially or fully edentulous | |||
| individuals. It is used to restore a | |||
| patient's chewing function. Smaller | |||
| implants (less than 6.0 mm) are | |||
| dedicated for immediate loading | |||
| when good primary stability is | |||
| achieved and with appropriate | |||
| occlusal loading. Larger implants | |||
| are dedicated for the molar region | |||
| and are indicated for delayed | |||
| loading. | The AnyOne Internal Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or | |||
| mandibular molar areas for the | |||
| purpose providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and overdentures) | |||
| in partially or fully edentulous | |||
| individuals. It is used to restore a | |||
| patient's chewing function. Smaller | |||
| implants (less than 6.0 mm) are | |||
| dedicated for immediate loading | |||
| when good primary stability is | |||
| achieved and with appropriate | |||
| occlusal loading. Larger implants | |||
| are dedicated for the molar region | |||
| and are indicated for delayed | |||
| loading. | |||
| Design | Image: Red dental implant | Image: Red dental implant | Image: Red dental implant |
| Diameter (Ø) | 5.5 mm | 4.5 mm | 4.0, 4.8, 5.1, 6.0 mm |
| Total Length | 13.65 mm | 15.7 mm | 12.0, 13.0 mm |
| Gingival (Cuff) | |||
| Height | 1.5 mm | 1.0 mm | 2.0, 3.0 mm |
| Post Height | 10.0 mm | 11.0 mm | 10.0 mm |
| Angulation | Straight | Straight | Straight |
| Connection | |||
| Interface | Internal Octa, Non-Octa | Internal Hex, Non-Hex | Internal Octa, Non-Octa |
| Internal Hex, Non-Hex | |||
| Material | Body: Gold Alloy / Sleeve: POM | Body: Gold Alloy / Sleeve: POM | Body: Gold Alloy / Sleeve: POM |
| Surface Treatment | N/A | N/A | N/A |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle of | |||
| Operation | The Gold Abutment is used in | ||
| conjunction with fixture to provide | |||
| support for screw or cement type | |||
| final prosthesis by casting with gold | |||
| alloy. It is connected to the Fixture | |||
| with Multi Post Screw. | The Gold Abutment is used in | ||
| conjunction with Fixture to provide | |||
| support for screw type final | |||
| prosthesis by casting with gold | |||
| alloy. It is connected to the Fixture | |||
| using the Screw. | The Gold Cylinder is used in | ||
| conjunction with Octa Abutment | |||
| and Multi-unit Abutment to provide | |||
| support for screw type final | |||
| prosthesis by casting with gold | |||
| alloy. It is connected to the | |||
| Abutment using the Screw. | |||
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the reference devices.
Indication for use, Design, Angulation, Material, Single Use, Sterilization and Principle of Operation
2. Differences
The subject device has the different characteristic for the followings compared to the reference devices.
Diameter, Total Length, Gingival (Cuff) Height and Post Height
- The dimension of subject device is slightly different with reference device 1 but the dimension of subject device lies within combined range of reference device 1 & 2. Also, it does not cause a matter in substantial equivalence since the size difference is very minor. -
- Connection Interface
The subject device has Internal Octa connection while the reference device 1 has Internal Hex connection, but has same connection structure as reference device 2. Also, both feature of Octa and Hex provides anti-rotational feature and multiple predicate & reference devices for Octa / Non-Octa are already presented in the other component comparison charts.
3. Discussion
- । The proposed Gold Abutment is being submitted to add in Megagen's existing prosthetic portfolio which had been FDA cleared. Therefore, the proposed Gold Abutment and reference devices have common in all the items in the comparison chart except the Diameter, Total Length, Gingival (Cuff) Height. These size differences are explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is straight type. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference devices.
22
CCM Abutment
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K210161 | K182448 | K123988 |
| Device Name | |||
| (Compatible | |||
| Implant System) | CCM Abutment | ||
| For AnyOne Onestage Implant | |||
| System | CCM Abutment | ||
| For AnyRidge Octa 1 Implant | |||
| System | CCM Cylinder | ||
| For AnyOne Internal Implant | |||
| System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for Use | |||
| Statement | The AnyOne Onestage Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols: | ||
| -Delayed loading | |||
| -Immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region. | The AnyRidge Octa 1 Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols: | ||
| -Delayed loading | |||
| -Immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region. | The AnyOne Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading. | ||
| Design | Image | Image | Image |
| Diameter (Ø) | 5.5 mm | 3.8 mm | 4.0, 5.1, 6.0 mm |
| Total Length | 13.65 mm | 14.65 mm | 12.0 mm |
| Gingival (Cuff) | |||
| Height | 1.5 mm | 1.0 mm | 2.0 mm |
| Post Height | 10.0 mm | 11.6 mm | 10.0 mm |
| Angulation | Straight | Straight | Straight |
| Connection | |||
| Interface | Internal Octa, | ||
| Internal Non-Octa | Internal Octa, | ||
| Internal Non-Octa | Internal Octa, Non-Octa | ||
| Material | Body: Co-Cr-Mo alloy | ||
| Sleeve: POM | Body: Co-Cr-Mo Alloy | ||
| Sleeve: POM | Body: Co-Cr-Mo Alloy | ||
| Sleeve: POM | |||
| Surface Treatment | N/A | N/A | N/A |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle of | |||
| Operation | The CCM Abutment is used in conjunction with fixture to provide support for screw or cement type final prosthesis by casting with CCM alloy. It is connected to the Fixture with Multi Post Screw. | The CCM Abutment is used in conjunction with Fixture to provide support for screw type final prosthesis by casting with CCM alloy. It is connected to the Fixture using the Screw. | The CCM Cylinder is used in conjunction with Octa Abutment to provide support for screw type final prosthesis by casting with CCM alloy. It is connected to the Abutment using the Screw. |
| Substantial Equivalence Discussion | |||
| 1. | |||
| Similarities | |||
| The subject device has the same characteristic for the followings compared to the predicate device. |
- Indication for use, Design, Angulation, Connection Interface, Material, Single Use, Sterilizati Operation
2. Differences
- The subject device has the different characteristic for the followings compared to the predicate device.
- Diameter, Total Length, Gingival (Cuff) Height and Post Height -The dimension of subject device is slightly different with predicate device but the dimension of subject device lies within combined range of predicate & reference devices. Also, it does not cause a matter in substantial equivalence since the size difference is very minor.
- Discussion
- The proposed CCM Abutment is being submitted to add in Megagen's existing prosthetic portfolio which had been -FDA cleared. Therefore, the proposed CCM Abutment and predicate device have common in all the items in the comparison chart except the Diameter, Total Length, Gingival (Cuff) Height and Post Height. These size differences are explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is straight type. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device.
23
Multi Post Screw
| Subject Device | Reference Device | |
|---|---|---|
| 510(k) No. | K210161 | K052369 |
| Device Name | ||
| (Compatible | ||
| Implant System) | Multi Post Screw | |
| For AnyOne Onestage Implant System | ExFeel Internal Screw | |
| For ExFeel Dental Implant System | ||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | ||
| Use Statement | The AnyOne Onestage Implant System is intended | |
| to be surgically placed in the maxillary or | ||
| mandibular arches for the purpose of providing | ||
| prosthetic support for dental restorations (Crown, | ||
| bridges, and overdentures) in partially or fully | ||
| edentulous individuals. It is used to restore a | ||
| patient's chewing function in the following | ||
| situations and with the clinical protocols: | ||
| -Delayed loading. | ||
| -Immediate loading when good | ||
| primary stability is achieved and with appropriate | ||
| occlusal loading. Larger implants are dedicated for | ||
| the molar region. | The ExFeel Dental Implant Systems are intended to be | |
| placed in the upper or lower jaw to support prosthetic | ||
| devices, such as artificial teeth, and to restore a patient's | ||
| chewing function. This may be accomplished using either | ||
| a two stage surgical procedure or a single stage surgical | ||
| procedure. | ||
| Design | ||
| Diameter (Ø) | 2.5 mm | 2.5 mm |
| Total Length | 8.1 mm | 8.1 mm |
| Connection | ||
| Interface | Internal Conical Connection | Internal Conical Connection |
| Material | Ti-6Al-4V ELI | |
| (ASTM F136-13) | Ti-6Al-4V ELI | |
| (ASTM F136-13) | ||
| Surface | ||
| Treatment | Machined | Machined |
| Single Use | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile |
| Principle of | ||
| Operation | The Multi Post Screw is used for connecting the | |
| Multi Post, EZ Post Abutment, Gold Abutment and | ||
| CCM Abutment to the Fixture. | The ExFeel Internal Screw is used for connecting | |
| the ExFeel Internal Multi-mount, EZ Post | ||
| Abutment, Gold Abutment and CCM Abutment to | ||
| the Fixture. | ||
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the reference device.
- Indication for use, Design, Diameter, Total Length, Connection Interface, Material, Surface Treatment, Single Use, -Sterilization and Principle of Operation.
Differences 2. N/A
3. Discussion
The proposed Multi Post Screw had been FDA cleared under K052639 with product name of 'ExFeel Internal Screw', but it is being submitted to change their identifier with modification of product name only. Therefore, the subject device and reference device have common in all the items in the comparison chart.
On the basis of the discussion above, it is concluded that the substantially equivalent to the reference device.
24
Solid Abutment
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K210161 | K182448 | K052369 |
| Device Name | |||
| (Compatible | |||
| Implant | |||
| System) | Solid Abutment | ||
| For AnyOne Onestage Implant | |||
| System | EZ Post Abutment | ||
| For AnyRidge Octa 1 Implant System | Solid Abutment | ||
| For ExFeel Dental Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | |||
| Use Statement | The AnyOne Onestage Implant | ||
| System is intended to be | |||
| surgically placed in the maxillary | |||
| or mandibular arches for the | |||
| purpose of providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used | |||
| to restore a patient's chewing | |||
| function in the following | |||
| situations and with the clinical | |||
| protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal | |||
| loading. Larger implants are | |||
| dedicated for the molar region. | The AnyRidge Octa 1 Implant | ||
| System is intended to be | |||
| surgically placed in the maxillary | |||
| or mandibular arches for the | |||
| purpose of providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used | |||
| to restore a patient's chewing | |||
| function in the following | |||
| situations and with the clinical | |||
| protocols: | |||
| -Delayed loading | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal | |||
| loading. Larger implants are | |||
| dedicated for the molar region. | The ExFeel Dental Implant Systems | ||
| are intended to be placed in the | |||
| upper or lower jaw to support | |||
| prosthetic devices, such as artificial | |||
| teeth, and to restore a patient's | |||
| chewing function. This may be | |||
| accomplished using either a two | |||
| stage surgical procedure or a single | |||
| stage surgical procedure. | |||
| Design | |||
| Diameter (Ø) | 3.5 mm | 4.0, 5.0, 6.0, 7.0 mm | 3.5 mm |
| Total Length | 9.0, 10.5, 12.0 mm | 7.85 - 16.35 mm | 9.0, 10.5, 12.0 mm |
| Post Height | 4.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm |
| Angulation | Straight | Straight | Straight |
| Connection | |||
| Interface | Internal Conical Connection | Internal Octa, Internal Non-Octa | Internal Conical Connection |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | CP Ti Grade 3 (ASTM F67-13) |
| Surface | |||
| Treatment | Machined | Anodizing | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle of | |||
| Operation | The Solid Abutment is a pre- | ||
| manufactured prosthetic | |||
| component connected to the | |||
| endosseous dental implant by its | |||
| threaded part for aid in | |||
| prosthetic rehabilitation. | The EZ Post Abutment is a | ||
| superstructure which is | |||
| connected to the Fixtures using | |||
| the Abutment Screw. It replaces | |||
| the functions of the missing teeth | |||
| as a dental abutment. | The Solid Abutment is a pre- | ||
| manufactured prosthetic | |||
| component connected to the | |||
| endosseous dental implant by | |||
| its threaded part for aid in | |||
| prosthetic rehabilitation. | |||
| Substantial Equivalence Discussion | |||
| 1. Similarities | |||
| The subject device has the same characteristic for the followings compared to the reference device. | |||
| Indication for use, Design, Diameter, Total Length, Post Height, Angulation, Connection Interface, Surface | |||
| Treatment, Single Use, Sterilization and Principle of Operation | |||
| 2. Differences | |||
| The subject device has the different characteristic for the followings compared to the reference device. | |||
| Material | |||
| The subject device is made of titanium alloy while the reference device is made entirely of commercially pure | |||
| titanium, but has made with same material with predicate device. Also, the multiple predicate & reference devices | |||
| for titanium alloy are presented in the other component comparison charts. | |||
| 3. Discussion | |||
| The proposed Solid Abutment had been FDA cleared under K052639, but it is being submitted to change their | |||
| identifier with modification of material only. Therefore, the proposed Solid Abutment and reference device have | |||
| common in all the items in the comparison chart except the material. The material difference is explained not | |||
| affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is a | |||
| straight type. On the basis of the discussion above, it is concluded that the subject device is substantially | |||
| equivalent to the predicate device. |
25
Solid Cap
| Subject Device | Reference Device | |
|---|---|---|
| 510(k) No. | K210161 | K052369 |
| Device Name | ||
| (Compatible | ||
| Implant System) | Solid Cap | |
| For AnyOne Onestage Implant System | Solid Protect Cap | |
| For ExFeel Dental Implant System | ||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | ||
| Use Statement | The AnyOne Onestage Implant System is intended | |
| to be surgically placed in the maxillary or | ||
| mandibular arches for the purpose of providing | ||
| prosthetic support for dental restorations (Crown, | ||
| bridges, and overdentures) in partially or fully | ||
| edentulous individuals. It is used to restore a | ||
| patient's chewing function in the following | ||
| situations and with the clinical protocols: | ||
| -Delayed loading. | ||
| -Immediate loading when good | ||
| primary stability is achieved and with appropriate | ||
| occlusal loading. Larger implants are dedicated for | ||
| the molar region. | The ExFeel Dental Implant Systems are intended to be | |
| placed in the upper or lower jaw to support prosthetic | ||
| devices, such as artificial teeth, and to restore a patient's | ||
| chewing function. This may be accomplished using either | ||
| a two stage surgical procedure or a single stage surgical | ||
| procedure. | ||
| Design | Image: U shape | Image: U shape |
| Diameter (Ø) | 5.7 mm | 5.7 mm |
| Total Length | 6.5, 8.0, 9.5 mm | 6.5, 8.0, 9.5 mm |
| Post Height | 4.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm |
| Material | POM | POM |
| Single Use | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile |
| Principle of | ||
| Operation | The Solid Cap is used for protecting a Solid | |
| Abutment after taking impression, and minimizing | ||
| irritation to tongue and oral mucosa. | The Solid Protect Cap is used for protecting a Solid | |
| Abutment after taking impression, and minimizing | ||
| irritation to tongue and oral mucosa. | ||
| Substantial Equivalence Discussion | ||
| 1. Similarities | ||
| The subject device has the same characteristic for the followings compared to the reference device. | ||
| Indication for use, Design, Diameter, Total Length, Post Height, Material, Single Use, Sterilization and Principle of | ||
| Operation. |
- Differences
N/A - Discussion
The proposed Solid Cap had been FDA cleared under K052639 with product name of 'Solid Protect Cap', but it is | | |
being submitted to change their identifier with modification of product name only. Therefore, the subject device and reference device have common in all the items in the comparison chart. Also, these devices were not tested for fatigue strength as they are not placed into occlusion. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference device.
26
Solid Post Abutment
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) No. | K210161 | K123988 | K160670 |
| Device Name | |||
| (Compatible | |||
| Implant System) | Solid Post Abutment | ||
| For AnyOne Onestage Implant | |||
| System | Solid Abutment | ||
| For AnyOne Internal Implant System | Solid Abutment | ||
| For ET US SS Prosthetic System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Indications for | |||
| Use Statement | The AnyOne Onestage Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or mandibular | |||
| arches for the purpose of providing | |||
| prosthetic support for dental | |||
| restorations (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used to | |||
| restore a patient's chewing function | |||
| in the following situations and with | |||
| the clinical protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and with | |||
| appropriate occlusal loading. Larger | |||
| implants are dedicated for the molar | |||
| region.. | The AnyOne Internal Implant System | ||
| is intended to be surgically placed in | |||
| the maxillary or mandibular molar | |||
| areas for the purpose providing | |||
| prosthetic support for dental | |||
| restorations (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used to | |||
| restore a patient's chewing function. | |||
| Smaller implants (less than 6.0 mm) | |||
| are dedicated for immediate loading | |||
| when good primary stability is | |||
| achieved and with appropriate | |||
| occlusal loading. Larger implants are | |||
| dedicated for the molar region and | |||
| are indicated for delayed loading. | ET System | ||
| The HIOSSEN Prosthetic system is | |||
| intended for use with a dental | |||
| implant to provide support for | |||
| prosthetic restorations such as | |||
| crowns, bridges, or over-dentures. | |||
| US/SS System | |||
| The OSSTEM Prosthetic system is | |||
| intended for use with a dental | |||
| implant to provide support for | |||
| prosthetic restorations such as | |||
| crowns, bridges, or over-dentures. | |||
| Design | Image: design | Image: design | Image: design |
| Diameter (Ø) | 4.9 mm | 4.0, 4.5, 5.5, 6.5 mm | 3.5, 4.3 mm |
| Total Length | 9.5, 10.5, 11.0, 11.5, 12.0, 12.5, | ||
| 13.0, 13.5, 14.5 mm | 11.2, 12.1 12.7, 13.2, 13.7, 14.2, | ||
| 14.7, 15.2, 15.7, 16.2, 16.7, | |||
| 17.2, 17.7, 18.7 mm | 9.5, 9.8, 11, 11.3, 12.5, 12.8 mm | ||
| Gingival (Cuff) | |||
| Height | 1.0, 2.0, 3.0 mm | 1.0, 1.5 2.5, 3.5, 4.5, 5.5mm | Not known |
| Post Height | 4.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0mm | Not known |
| Angulation | Straight | Straight | Straight |
| Connection | |||
| Interface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | Titanium Alloy |
| Surface | |||
| Treatment | Machined | Machined | Not known |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle of | |||
| Operation | The Solid Post Abutment is a pre- | ||
| manufactured prosthetic | |||
| component connected to the | |||
| endosseous dental implant by its | |||
| threaded part for aid in | |||
| prosthetic rehabilitation. | The Solid Abutment is a pre- | ||
| manufactured prosthetic | |||
| component connected to the | |||
| endosseous dental implant by its | |||
| threaded part for aid in | |||
| prosthetic rehabilitation. | The Solid Abutment is a pre- | ||
| manufactured prosthetic | |||
| component connected to the | |||
| endosseous dental implant by its | |||
| threaded part for aid in | |||
| prosthetic rehabilitation. |
1. Similarities
The subject device has the same characteristic for the followings compared to the reference devices.
- Indication for use, Design, Post Height, Angulation, Connection Interface, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation
Differences 2.
The subject device has the different characteristic for the followings compared to the reference devices.
- Diameter & Gingival (Cuff) Heights -
- The diameter and Gingival (Cuff) Height of subject device is slightly different with reference devices, but these dimensions lie within the range of reference device 1.
-Total Length
The Total Length of subject device is slightly different with reference devices, but it lies within combined range of reference device 1&2, and has similar Gingival Height with reference device 1. Also, it does not cause a matter in substantial equivalence since the size difference is very minor, and the variety of the size can be possible to operate more precise treatment to meet each patient's condition.
3. Discussion
- The proposed Solid Post Abutment and reference devices have common in all the items in the comparison chart " except the Diameter, Total Length and Gingival (Cuff) Height. These size differences are explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is straight type. On the basis of the discussion above, it is concluded that the substantially equivalent to the reference devices.
27
Solid Post Cap
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) No. | K210161 | K052369 | K123988 |
| Device Name | |||
| (Compatible | |||
| Implant System) | Solid Post Cap | ||
| For AnyOne Onestage Implant | |||
| System | Solid Protect Cap | ||
| For ExFeel Dental Implant System | Comfort Cap | ||
| For AnyOne Internal Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | |||
| Use Statement | The AnyOne Onestage Implant | ||
| System is intended to be | |||
| surgically placed in the maxillary | |||
| or mandibular arches for the | |||
| purpose of providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used | |||
| to restore a patient's chewing | |||
| function in the following | |||
| situations and with the clinical | |||
| protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal | |||
| loading. Larger implants are | |||
| dedicated for the molar region. | The ExFeel Dental Implant Systems | ||
| are intended to be placed in the | |||
| upper or lower jaw to support | |||
| prosthetic devices, such as artificial | |||
| teeth, and to restore a patient's | |||
| chewing function. This may be | |||
| accomplished using either a two | |||
| stage surgical procedure or a single | |||
| stage surgical procedure. | The AnyOne Internal Implant System | ||
| is intended to be surgically placed in | |||
| the maxillary or mandibular molar | |||
| areas for the purpose providing | |||
| prosthetic support for dental | |||
| restorations (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used to | |||
| restore a patient's chewing function. | |||
| Smaller implants (less than 6.0 mm) | |||
| are dedicated for immediate loading | |||
| when good primary stability is | |||
| achieved and with appropriate | |||
| occlusal loading. Larger implants are | |||
| dedicated for the molar region and | |||
| are indicated for delayed loading. | |||
| Design | Image: Subject Device Design | Image: Reference Device 1 Design | Image: Reference Device 2 Design |
| Diameter (Ø) | 5.3 mm | 5.7 mm | 4.0, 4.5, 5.5, 6.5 mm |
| Total Length | 6.5, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0, | ||
| 10.5, 11.5 mm | 6.5, 8.0, 9.5 mm | 5.4, 5.5, 5.6, 6.9, 7.0, 7.1, 8.4, | |
| 8.5, 8.6 mm | |||
| Gingival (Cuff) | |||
| Height | 1.0, 2.0, 3.0 mm | N/A | N/A |
| Post Height | 4.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm |
| Material | POM | POM | POM |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle of | |||
| Operation | The Solid Post Cap is used for | ||
| protecting a Solid Post Abutment | |||
| after taking impression, and | |||
| minimizing irritation to tongue | |||
| and oral mucosa. | The Solid Protect Cap is used for | ||
| protecting a Solid Abutment | |||
| after taking impression, and | |||
| minimizing irritation to tongue | |||
| and oral mucosa. | The Comfort Cap is used for | ||
| protecting a Solid Abutment | |||
| after taking impression, and | |||
| minimizing irritation to tongue | |||
| and oral mucosa. | |||
| Substantial Equivalence Discussion | |||
| 1. Similarities |
The subject device has the same characteristic for the followings compared to the reference devices.
Indication for use, Design, Post Height, Material, Single Use, Sterilization and Principle of Operation.
2. Differences
The subject device has the different characteristic for the followings compared to the reference devices.
- Diameter, Total Length and Gingival (Cuff) Height -The diameter of subject device is slightly different with reference device 1, but it lies within combined range of reference device 1&2. The total length is slightly different with reference device 1, but has same post height with reference device 1&2. And, the subject device has the cuff height corresponding to the its compatible abutment, while the reference devices are not applicable, but these do not cause a matter in substantial equivalence since the size difference is very minor, and the variety of the size can be possible to operate more precise treatment to meet each patient's
condition. 3. Discussion
- The proposed Solid Post Cap and reference devices have common in all the items in the comparison chart except the Diameter, Total Length and Gingival (Cuff) Height. These size differences are explained not affecting on the substantial equivalence. Also, these devices were not tested for fatigue strength as they are not placed into occlusion. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference devices.
28
Octa Abutment
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K210161 | K182448 | K171027 |
| Device Name | |||
| (Compatible Implant | |||
| System) | Octa Abutment | ||
| For AnyOne Onestage Implant | |||
| System | Octa Abutment | ||
| For AnyRidge Octa 1 Implant | |||
| System | Octa Abutment | ||
| Dentis Dental Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Dentis Co., Ltd. |
| Indications for Use | |||
| Statement | The AnyOne Onestage Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary | |||
| or | |||
| mandibular arches for the purpose | |||
| of providing prosthetic support for | |||
| dental restorations (Crown, | |||
| bridges, and overdentures) in | |||
| partially or fully edentulous | |||
| individuals. It is used to restore a | |||
| patient's chewing function in the | |||
| following situations and with the | |||
| clinical protocols: | |||
| -Delayed loading | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal loading. | |||
| Larger implants are dedicated for | |||
| the molar region. | The AnyRidge Octa 1 Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary | |||
| or | |||
| mandibular arches for the purpose | |||
| of providing prosthetic support for | |||
| dental restorations (Crown, | |||
| bridges, and overdentures) in | |||
| partially or fully edentulous | |||
| individuals. It is used to restore a | |||
| patient's chewing function in the | |||
| following situations and with the | |||
| clinical protocols: | |||
| -Delayed loading | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal loading. | |||
| Larger implants are dedicated for | |||
| the molar region. | The Dentis Dental Implant System is | ||
| an endosseous dental implant that | |||
| is indicated for surgical placement | |||
| in the upper and lower jaw arches, | |||
| to provide a root form means for | |||
| single or multiple-units prosthetic | |||
| appliance attachment to restore a | |||
| patient 's chewing function. | |||
| Implants can be placed with a | |||
| conventional two stage surgical | |||
| process with an option for | |||
| transmucosal healing or they can | |||
| be placed in a single stage surgical | |||
| process for immediate loading | |||
| when good primary stability has | |||
| been achieved and with | |||
| appropriate occlusal loading. | |||
| Design | |||
| Diameter (Ø) | 3.5 mm | 3.8, 4.8, 5.8 mm | 3.5, 4.3 |
| Total Length | 6.5 mm | 7.85, 8.85, 9.35, 9.85, 10.35, | |
| 10.85, 11.35, 11.85, 12.35, | |||
| 12.85, 13.35, 13.85, 14.85 mm | 7.0,7.3 mm | ||
| Gingival (Cuff) | |||
| Height | N/A | 1.0, 2.0, 3.0, 4.0, 5.0 mm | Not known |
| Post Height | 1.5 mm | 1.5 mm | Not known |
| Angulation | Straight | Straight | Straight |
| Connection | |||
| Interface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) |
| Surface Treatment | Machined | Anodizing | Not known |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle of | |||
| Operation | The Octa Abutment is a pre- | ||
| manufactured prosthetic | |||
| component connected to the | |||
| endosseous dental implant by | |||
| its threaded part for aid in | |||
| prosthetic rehabilitation. | |||
| This device is a two piece | |||
| abutment that is always used | |||
| with a cylinder (such as the | |||
| Temporary Cylinder, EZ Post | |||
| Cylinder, Gold Cylinder, or CCM | |||
| Cylinder) to form the final | |||
| abutment. | The Octa Abutment is a pre- | ||
| manufactured prosthetic | |||
| component connected to the | |||
| endosseous dental implant by | |||
| its threaded part for aid in | |||
| prosthetic rehabilitation. | |||
| This device is a two piece | |||
| abutment that is always used | |||
| with a cylinder (such as the | |||
| Temporary Cylinder, EZ Post | |||
| Cylinder, Gold Cylinder, or CCM | |||
| Cylinder) to form the final | |||
| abutment. | The Octa Abutment is a pre- | ||
| manufactured prosthetic | |||
| component connected to the | |||
| endosseous dental implant by | |||
| its threaded part for aid in | |||
| prosthetic rehabilitation. | |||
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the predicate device.
Indication for use, Design, Post Height, Angulation, Connection Interface, Material, Single Use, Sterilization and -Principle of Operation
2. Differences
The subject device has the different characteristic for the followings compared to the predicate device.
Diameter, Total Length and Gingival (Cuff) Height
Blameter of subject device is slightly different with predicate device, but it lies within combined range of predicate & Reference devices. The total length is slightly different with predicate device, but has same post height with predicate devices. The subject device is not applicable the cuff height while the predicate device has the cuff height. That's why the total length of subject device is slightly shorter than predicate device. However, it can be replaced with Fixture's cuff height connecting the proposed fixture and octa abutment. The difference in cuff height is acceptable for the subject device as it is intended to be used with a tissue level implant, with a portion of the cuff height built into the implant, whereas the predicate device is intended to be used with a bone level implant which requires a cuff height for all abutments.
29
3. Discussion 1
The proposed Octa Abutment is being submitted to add in Megagen's existing prosthetic portfolio which had been FDA cleared. Therefore, the proposed Octa Abutment and predicate device have common in all the items in the comparison chart except the Diameter, Total Length and Gingival (Cuff) Height. These size differences are explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is straight type. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device.
30
Healing Cap
| Subject Device | Reference Device | |
|---|---|---|
| 510(k) No. | K210161 | K123988 |
| Device Name | ||
| (Compatible | ||
| Implant System) | Healing Cap | |
| For AnyOne Onestage Implant System | Octa Healing Cap | |
| For AnyOne Internal Implant System | ||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | ||
| Use Statement | The AnyOne Onestage Implant System is intended | |
| to be surgically placed in the maxillary or | ||
| mandibular arches for the purpose of providing | ||
| prosthetic support for dental restorations (Crown, | ||
| bridges, and overdentures) in partially or fully | ||
| edentulous individuals. It is used to restore a | ||
| patient's chewing function in the following | ||
| situations and with the clinical protocols: | ||
| -Delayed loading. | ||
| -Immediate loading when good | ||
| primary stability is achieved and with appropriate | ||
| occlusal loading. Larger implants are dedicated for | ||
| the molar region. | The AnyOne Internal Implant System is intended to be | |
| surgically placed in the maxillary or mandibular molar | ||
| areas for the purpose providing prosthetic support for | ||
| dental restorations (Crown, bridges, and overdentures) | ||
| in partially or fully edentulous individuals. It is used to | ||
| restore a patient's chewing function. Smaller implants | ||
| (less than 6.0 mm) are dedicated for immediate loading | ||
| when good primary stability is achieved and with | ||
| appropriate occlusal loading. Larger implants are | ||
| dedicated for the molar region and are indicated for | ||
| delayed loading. | ||
| Design | Image: Healing Cap | Image: Octa Healing Cap |
| Diameter (Ø) | 5.2 mm | 5.2 mm |
| Total Length | 4.0 mm | 4.0 mm |
| Connection | ||
| Interface | Two-piece (with titanium alloy screw) | Two-piece (with titanium alloy screw) |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) |
| Surface | ||
| Treatment | Machined | Machined |
| Single Use | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile |
| Principle of | ||
| Operation | The Healing Cap is used for protecting Octa | |
| Abutment and minimizing irritation to tongue and | ||
| oral mucosa during period of gingival healing. It is | ||
| connected to the Abutment using Abutment | ||
| Screw. | The Octa Healing Cap is used for protecting Octa | |
| Abutment and minimizing irritation to tongue and | ||
| oral mucosa during period of gingival healing. It is | ||
| connected to the Abutment using Abutment | ||
| Screw. | ||
| Substantial Equivalence Discussion | ||
| 1. | ||
| Similarities |
The subject device has the same characteristic for the followings compared to the reference device.
Indication for use, Design, Diameter, Total Length, Connection Interface, Material, Surface Treatment, Single Use, -Sterilization and Principle of Operation.
2. Differences
N/A 3. Discussion
The proposed Healing Cap had been FDA cleared under K123988 with product name of 'Octa Healing Cap', but it is being submitted to change their identifier with modification of product name only. Therefore, the subject device and reference device have common in all the items in the comparison chart. Also, these devices were not tested for fatigue strength as they are not placed into occlusion. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference device.
31
Temporary Cylinder
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K210161 | K182448 | K123988 |
| Device Name | |||
| (Compatible | |||
| Implant | |||
| System) | Temporary Cylinder | ||
| For AnyOne Onestage Implant | |||
| System | Temporary Abutment | ||
| For AnyRidge Octa 1 Implant | |||
| System | Temporary Cylinder | ||
| For AnyOne Internal Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | |||
| Use Statement | The AnyOne Onestage Implant | ||
| System is intended to be | |||
| surgically placed in the maxillary | |||
| or mandibular arches for the | |||
| purpose of providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used | |||
| to restore a patient's chewing | |||
| function in the following | |||
| situations and with the clinical | |||
| protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal | |||
| loading. Larger implants are | |||
| dedicated for the molar region. | The AnyRidge Octa 1 Implant System | ||
| is intended to be surgically placed in | |||
| the maxillary or mandibular arches | |||
| for the purpose of providing | |||
| prosthetic support for dental | |||
| restorations (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used to | |||
| restore a patient's chewing function | |||
| in the following situations and with | |||
| the clinical protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and with | |||
| appropriate occlusal loading. Larger | |||
| implants are dedicated for the molar | |||
| region. | The AnyOne Internal Implant System | ||
| is intended to be surgically placed in | |||
| the maxillary or mandibular molar | |||
| areas for the purpose providing | |||
| prosthetic support for dental | |||
| restorations (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used to | |||
| restore a patient's chewing function. | |||
| Smaller implants (less than 6.0 mm) | |||
| are dedicated for immediate loading | |||
| when good primary stability is | |||
| achieved and with appropriate | |||
| occlusal loading. Larger implants are | |||
| dedicated for the molar region and | |||
| are indicated for delayed loading. | |||
| Design | Image: Design of Temporary Cylinder | Image: Design of Temporary Abutment | Image: Design of Temporary Cylinder |
| Diameter (Ø) | 5.0 mm | 4.0, 4.5, 5.0 mm | 5.0 mm |
| Total Length | 10.0 mm | 14.85, 15.85, 16.35, 17.35 mm | 10.0 mm |
| Post Height | 7.0 mm | 10 mm | 7.0 mm |
| Angulation | Straight | Straight | Straight |
| Connection | |||
| Interface | Octa, Non-Octa | Octa, Non-Octa | Octa, Non-Octa |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | CP Ti Grade 4 (ASTM F67-13) |
| Surface | |||
| Treatment | Machined | Machined | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle of | |||
| Operation | The Temporary Cylinder is used | ||
| in conjunction with Octa | |||
| Abutment to provide support for | |||
| provisional restoration. It is | |||
| connected to the Abutment | |||
| using Abutment Screw | The Temporary Abutment is used | ||
| in conjunction with Fixture to | |||
| provide support for provisional | |||
| restoration. It is connected to | |||
| Fixture using the Screw. | The Temporary Cylinder is used | ||
| in conjunction with Octa | |||
| Abutment to provide support for | |||
| provisional restoration. It is | |||
| connected to the Abutment | |||
| using the Screw. | |||
| Substantial Equivalence Discussion | |||
| 1. | |||
| Similarities | |||
| The subject device has the same characteristic for the followings compared to the reference device. | |||
| Indication for use, Design, Diameter, Total Length, Post Height, Angulation, Connection Interface, Surface | |||
| Subject Device | Primary Predicate Device | Reference Device | |
| 510(k) No. | K210161 | K182448 | K123988 |
| Device Name | |||
| (Compatible | |||
| Implant | |||
| System) | EZ Post Cylinder | ||
| For AnyOne Onestage Implant | |||
| System | EZ Post Abutment | ||
| For AnyRidge Octa 1 Implant System | EZ Post Cylinder | ||
| For AnyOne Internal Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | |||
| Use Statement | The AnyOne Onestage Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or mandibular | |||
| arches for the purpose of providing | |||
| prosthetic support for dental | |||
| restorations (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used to | |||
| restore a patient's chewing function | |||
| in the following situations and with | |||
| the clinical protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and with | |||
| appropriate occlusal loading. Larger | |||
| implants are dedicated for the molar | |||
| region. | The AnyRidge Octa 1 Implant | ||
| System is intended to be | |||
| surgically placed in the maxillary | |||
| or mandibular arches for the | |||
| purpose of providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used | |||
| to restore a patient's chewing | |||
| function in the following | |||
| situations and with the clinical | |||
| protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal | |||
| loading. Larger implants are | |||
| dedicated for the molar region. | The AnyOne Internal Implant System | ||
| is intended to be surgically placed in | |||
| the maxillary or mandibular molar | |||
| areas for the purpose providing | |||
| prosthetic support for dental | |||
| restorations (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used to | |||
| restore a patient's chewing function. | |||
| Smaller implants (less than 6.0 mm) | |||
| are dedicated for immediate loading | |||
| when good primary stability is | |||
| achieved and with appropriate | |||
| occlusal loading. Larger implants are | |||
| dedicated for the molar region and | |||
| are indicated for delayed loading. | |||
| Design | |||
| Diameter (Ø) | 5.0 mm | 4.0, 5.0, 6.0, 7.0 mm | 5.0 mm |
| Total Length | 5.5, 7.0 mm | 7.85 - 16.35 mm | 5.5, 7.0 mm |
| Post Height | 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm | 5.5, 7.0 mm |
| Angulation | Straight | Straight | Straight |
| Connection | |||
| Interface | Octa, Non-Octa | Octa, Non-Octa | Octa, Non-Octa |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | CP Ti Grade 4 (ASTM F67-13) |
| Surface | |||
| Treatment | Anodizing | Anodizing | Anodizing |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle of | |||
| Operation | The EZ Post Cylinder is used in | ||
| conjunction with Octa Abutment | |||
| to provide support for cement | |||
| and screw type final prosthesis. | |||
| It is connected to the Abutment | |||
| using Abutment Screw. | The EZ Post Abutment is a | ||
| superstructure which is | |||
| connected to the Fixtures using | |||
| the Abutment Screw. It replaces | |||
| the functions of the missing | |||
| teeth as a dental abutment. | The EZ Post Cylinder is used in | ||
| conjunction with Octa Abutment | |||
| to provide support for cement | |||
| and screw type final prosthesis. | |||
| It is connected to the Abutment | |||
| using Abutment Screw. | |||
| Substantial Equivalence Discussion | |||
| 1. Similarities | |||
| The subject device has the same characteristic for the followings compared to the reference device. | |||
| Indication for use, Design, Diameter, Total Length, Post Height, Angulation, Connection Interface, Surface | |||
| Treatment, Single Use, Sterilization and Principle of Operation | |||
| 2. Differences | |||
| The subject device has the different characteristic for the followings compared to the reference device. | |||
| Material | |||
| The subject device is made of titanium alloy while the reference device is made entirely of commercially pure | |||
| titanium, but has made with same material with predicate device. Also, the multiple predicate & reference devices | |||
| for titanium alloy are presented in the other component comparison charts. | |||
| 3. Discussion | |||
| The proposed EZ Post Cylinder had been FDA cleared under K123988, but it is being submitted to change their | |||
| identifier with modification of material only. Therefore, the proposed EZ Post Cylinder and reference device have | |||
| common in all the items in the comparison chart except the material. The material difference is explained not | |||
| affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is a | |||
| straight type. On the basis of the discussion above, it is concluded that the subject device is substantially | |||
| equivalent to the predicate device. | |||
| Subject Device | Reference Device | ||
| 510(k) No. | K210161 | K123988 | |
| Device Name | |||
| (Compatible Implant | |||
| System) | Gold Cylinder | ||
| For AnyOne Onestage Implant System | Gold Cylinder | ||
| For AnyOne Internal Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | |
| Indications for Use | |||
| Statement | The AnyOne Onestage Implant System is | ||
| intended to be surgically placed in the maxillary | |||
| or mandibular arches for the purpose of | |||
| providing prosthetic support for dental | |||
| restorations (Crown, bridges, and | |||
| overdentures) in partially or fully edentulous | |||
| individuals. It is used to restore a patient's | |||
| chewing function in the following situations | |||
| and with the clinical protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and with | |||
| appropriate occlusal loading. Larger implants | |||
| are dedicated for the molar region. | The AnyOne Internal Implant System is intended to | ||
| be surgically placed in the maxillary or mandibular | |||
| molar areas for the purpose providing prosthetic | |||
| support for dental restorations (Crown, bridges, and | |||
| overdentures) in partially or fully edentulous | |||
| individuals. It is used to restore a patient's chewing | |||
| function. Smaller implants (less than 6.0 mm) are | |||
| dedicated for immediate loading when good primary | |||
| stability is achieved and with appropriate occlusal | |||
| loading. Larger implants are dedicated for the molar | |||
| region and are indicated for delayed loading. | |||
| Design | Image: red cylinder | Image: red cylinder | |
| Diameter (Ø) | 5.1 mm | 5.1 mm | |
| Total Length | 12.0 mm | 12.0 mm | |
| Post Height | 10.0 mm | 10.0 mm | |
| Angulation | Straight | Straight | |
| Connection Interface | Octa, Non-Octa | Octa, Non-Octa | |
| Material | Body: Gold Alloy | ||
| Sleeve: POM | Body: Gold Alloy | ||
| Sleeve: POM | |||
| Surface Treatment | N/A | N/A | |
| Single Use | Yes | Yes | |
| Sterilization | Non-sterile | Non-sterile | |
| Principle of Operation | The Gold Cylinder is used in conjunction with | ||
| Octa Abutment to provide support for screw | |||
| type final prosthesis by casting with Gold alloy. | |||
| It is connected to the Abutment using | |||
| Abutment Screw. | The Gold Cylinder is used in conjunction with | ||
| Octa Abutment to provide support for screw | |||
| type final prosthesis by casting with Gold alloy. | |||
| It is connected to the Abutment using | |||
| Abutment Screw. | |||
| Substantial Equivalence Discussion | |||
| 1. Similarities | |||
| The subject device has the same characteristic for the followings compared to the reference device. |
-
Indication for use, Design, Diameter, Total Length, Post Height, Angulation, Connection Interface, Material, Single
Use, Sterilization and Principle of Operation | | | |
| 2. Differences
The subject device has the different characteristic for the followings compared to the reference device. | | | | -
Treatment, Single Use, Sterilization and Principle of Operation
2. Differences
- The subject device has the different characteristic for the followings compared to the reference device.
- Material -The subject device is made of titanium alloy while the reference device is made entirely of commercially pure titanium, but has made with same material with predicate device. Also, the multiple predicate & reference devices for titanium alloy are presented in the other component comparison charts.
- Discussion
- The proposed Temporary Cylinder had been FDA cleared under K123988, but it is being submitted to change their identifier with modification of material only. Therefore, the proposed Temporary Cylinder and reference device have common in all the items in the comparison chart except the material difference is explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is a straight type. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device.
32
EZ Post Cylinder
33
Gold Cylinder
- Discussion
The proposed Gold Cylinder had been FDA cleared under K123988, but it is being submitted to change their identifier only without any modification. Therefore, the proposed Gold Cylinder and reference device have common in all the items in the comparison chart. Also, the fatigue testing is not considered since the proposed device is a straight type. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference device.
34
CCM Cylinder
| Subject Device | Reference Device | |
|---|---|---|
| 510(k) No. | K210161 | K123988 |
| Device Name | ||
| (Compatible Implant | ||
| System) | CCM Cylinder | |
| For AnyOne Onestage Implant System | CCM Cylinder | |
| For AnyOne Internal Implant System | ||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for Use | ||
| Statement | The AnyOne Onestage Implant System is | |
| intended to be surgically placed in the maxillary | ||
| or mandibular arches for the purpose of | ||
| providing prosthetic support for dental | ||
| restorations (Crown, bridges, and | ||
| overdentures) in partially or fully edentulous | ||
| individuals. It is used to restore a patient's | ||
| chewing function in the following situations | ||
| and with the clinical protocols: | ||
| -Delayed loading. | ||
| -Immediate loading when good | ||
| primary stability is achieved and with | ||
| appropriate occlusal loading. Larger implants | ||
| are dedicated for the molar region. | The AnyOne Internal Implant System is intended to | |
| be surgically placed in the maxillary or mandibular | ||
| molar areas for the purpose providing prosthetic | ||
| support for dental restorations (Crown, bridges, and | ||
| overdentures) in partially or fully edentulous | ||
| individuals. It is used to restore a patient's chewing | ||
| function. Smaller implants (less than 6.0 mm) are | ||
| dedicated for immediate loading when good primary | ||
| stability is achieved and with appropriate occlusal | ||
| loading. Larger implants are dedicated for the molar | ||
| region and are indicated for delayed loading. | ||
| Design | Image: [implant design] | Image: [implant design] |
| Diameter (Ø) | 5.1 mm | 5.1 mm |
| Total Length | 12.0 mm | 12.0 mm |
| Post Height | 10.0 mm | 10.0 mm |
| Angulation | Straight | Straight |
| Connection Interface | Octa, Non-Octa | Octa, Non-Octa |
| Material | Body: Co-Cr-Mo alloy | |
| Sleeve: POM | Body: Co-Cr-Mo alloy | |
| Sleeve: POM | ||
| Surface Treatment | N/A | N/A |
| Single Use | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile |
| Principle of Operation | The CCM Cylinder is used in conjunction with | |
| Octa Abutment to provide support for screw | ||
| type final prosthesis by casting with CCM alloy. | ||
| It is connected to the Abutment using | ||
| Abutment Screw. | The CCM Cylinder is used in conjunction with | |
| Octa Abutment to provide support for screw | ||
| type final prosthesis by casting with CCM alloy. | ||
| It is connected to the Abutment using | ||
| Abutment Screw. | ||
| Substantial Equivalence Discussion | ||
| 1. Similarities | ||
| The subject device has the same characteristic for the followings compared to the reference device. |
- Indication for use, Design, Diameter, Total Length, Post Height, Angulation, Connection Interface, Material, Single
Use, Sterilization and Principle of Operation | | |
| 2. Differences
The subject device has the different characteristic for the followings compared to the reference device. - N/A | | |
| 3. Discussion
The proposed CCM Cylinder had been FDA cleared under K123988, but it is being submitted to change their
identifier only without any modification. Therefore, the proposed CCM Cylinder and reference device have common | | |
in all the items in the comparison chart. Also, the fatigue testing is not considered since is a straight type. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent
to the reference device.
35
Abutment Screw
| Subject Device | Reference Device 1 | Reference Device 2 | Subject Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | Reference Device 4 | ||
|---|---|---|---|---|---|---|---|---|---|
| 510(k) No. | K210161 | K123988 | K123988 | 510(k) No. | K210161 | K192614 | K150537 | K182091 | K192614 |
| Device Name | |||||||||
| (Compatible | |||||||||
| Implant System) | Abutment Screw | ||||||||
| For AnyOne Onestage Implant | |||||||||
| System | Octa Abutment Screw | ||||||||
| For AnyOne Internal Implant System | Multi-unit Abutment Screw | ||||||||
| For AnyOne Internal Implant System | Device Name | ||||||||
| (Compatible | |||||||||
| Implant | |||||||||
| System) | Meg-Loc | ||||||||
| Abutment | |||||||||
| For AnyOne Onestage | |||||||||
| Implant System | Meg-Loc | ||||||||
| Abutment | |||||||||
| For ExFeel Dental | |||||||||
| Implant System | Meg-Rhein | ||||||||
| Abutment | |||||||||
| For MiNi Internal | |||||||||
| Implant System | Port Abutment | ||||||||
| For TS SA, SS SA, US | |||||||||
| SA, MS SA Implant | Meg-Magnet | ||||||||
| Abutment | |||||||||
| For | |||||||||
| AnyRidge, AnyOne, | |||||||||
| AnyRidge Octa 1, | |||||||||
| ExFeel Internal | |||||||||
| Implant System | |||||||||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Osstem Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | |||||||||
| Use Statement | The AnyOne Onestage Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols: | ||||||||
| -Delayed loading. | |||||||||
| -Immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region. | The AnyOne Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading. | The AnyOne Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading. | Indications | ||||||
| for Use | |||||||||
| Statement | The AnyOne | ||||||||
| Onestage Implant | |||||||||
| System is intended to | |||||||||
| be surgically placed | |||||||||
| in the maxillary or | |||||||||
| mandibular arches | |||||||||
| for the purpose of | |||||||||
| providing prosthetic | |||||||||
| support for dental | |||||||||
| restorations (Crown, | |||||||||
| bridges, and | |||||||||
| overdentures) in | |||||||||
| partially or fully | |||||||||
| edentulous | |||||||||
| individuals. It is used | |||||||||
| to restore a patient's | |||||||||
| chewing function in | |||||||||
| the following | |||||||||
| situations and with | |||||||||
| the clinical protocols: | |||||||||
| -Delayed loading. | |||||||||
| -Immediate loading | |||||||||
| when good | |||||||||
| primary stability is | |||||||||
| achieved and with | |||||||||
| appropriate occlusal | |||||||||
| loading. Larger | |||||||||
| implants are | |||||||||
| dedicated for the | |||||||||
| molar region. | Meg-Ball Attachment | ||||||||
| System, Meg-Loc | |||||||||
| Abutment, Meg- | |||||||||
| Magnet Abutment is | |||||||||
| intended to be used | |||||||||
| in the upper or lower | |||||||||
| jaw and used for | |||||||||
| supporting tooth | |||||||||
| replacements to | |||||||||
| restore chewing | |||||||||
| function. Intended | |||||||||
| for fully edentulous | |||||||||
| jaw retaining a tissue | |||||||||
| supported | |||||||||
| overdenture. | |||||||||
| The abutments in | |||||||||
| combination with | |||||||||
| endosseous implants | |||||||||
| are used as the | |||||||||
| foundation for | |||||||||
| anchoring tooth | |||||||||
| replacements in | |||||||||
| either jaw. The | |||||||||
| attachments are | |||||||||
| used in fixed | |||||||||
| overdenture | |||||||||
| restorations that can | |||||||||
| be attached | |||||||||
| with a snap-in | |||||||||
| system. | The MiNi Internal | ||||||||
| Implant System is | |||||||||
| intended for two- | |||||||||
| stage surgical | |||||||||
| procedures in the | |||||||||
| following | |||||||||
| situations and with | |||||||||
| the following clinical | |||||||||
| protocols: |
- The intended use
for the 3.0 mm
diameter MiNi
implant is limited to
the replacement of
maxillary lateral
incisors and
mandibular incisors. - Immediate
placement in
extraction sites and
in situations with a
partially or
completely
healed alveolar ridge. - It is intended for
delayed loading. | Osstem Abutment
System is intended
for use with a dental
implant to provide
support for
prosthetic
restorations such as
crowns, bridges, or
overdentures. | Meg-Ball Attachment
System, Meg-Loc
Abutment, Meg-
Magnet Abutment is
intended to be used
in the
upper or lower jaw
and used for
supporting tooth
replacements to
restore chewing
function. Intended
for fully edentulous
jaw retaining a tissue
supported
overdenture.
The abutments in
combination with
endosseous implants
are used as the
foundation for
anchoring tooth
replacements in
either jaw. The
attachments are
used in fixed
overdenture
restorations that can
be attached
with a snap-in
system. |
| Design | Image: Abutment Screw | Image: Octa Abutment Screw | Image: Multi-unit Abutment Screw | Design | | | | | |
| Diameter ( $Ø$ ) | 2.5, 2.6 mm | 2.5 mm | 2.95 mm | Diameter (Ø) | 3.89 mm | 3.89 mm | 3.0, 3.1, 3.4 mm | 3.5, 3.7, 4.1, 4.8,
5.1 mm | 4.5, 5.0 mm |
| Total Length | 4.85, 5.5 mm | 4.85 mm | 11.5, 12.5, 13.5, 14.5, 15.5 mm | Total Length | 7.45, 7.95, 8.95,
9.95, 10.95, 11.95,
12.95, 13.95 mm | 7.45, 7.95, 8.95,
9.95, 10.95, 11.95,
12.95 mm | 6.55, 6.95, 7.25,
7.75, 7.95, 8.40,
8.75, 8.90, 8.95,
9.75, 9.90, 9.95,
10.75, 10.90,
10.95, 11.75,
11.90, 11.95,
12.75, 12.90, 13.90
mm | Unknown | 5.65, 5.85, 6.15,
6.2, 6.75, 6.8,
6.9, 7.15, 7.2,
7.3, 7.4, 7.75,
8.15, 8.2, 8.3,
8.4, 8.75, 9.15,
9.2, 9.3, 9.4,
9.75, 10.15, 10.2,
10.3, 10.4, 10.75,
11.2, 11.3, 11.4,
11.75 mm |
| Connection
Interface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection | Gingival
(Cuff) Height | 0.3, 0.8, 1.8, 2.8,
3.8, 4.8, 5.8, 6.8
mm | 0.3, 0.8, 1.8, 2.8,
3.8, 4.8, 5.8 mm | 0.2, 0.3, 1.0, 2.0,
3.0, 4.0, 5.0, 6.0
mm | 1.0, 2.0, 3.0, 4.0,
5.0, 6.0, 7.0 mm | 0.3, 0.8, 1.8, 2.8,
3.8, 4.8, 5.8 mm |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | Post Height | 1.5 mm | 1.5 mm | 1.5, 1.7 mm | Unknown | N/A |
| Surface
Treatment | Machined | Machined | Machined | Angulation
Connection | Up to 20°
Internal Conical | Up to 20°
Internal Conical | Straight
Internal Conical | Straight
Internal Conical | Straight
Internal Conical |
| Single Use | Yes | Yes | Yes | Interface | Connection | Connection | Connection | Connection | Connection |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Material | Ti-6Al-4V ELI
(ASTM F136-13) | Ti-6Al-4V ELI
(ASTM F136-13) | Ti-6Al-4V ELI
(ASTM F136-13) | Ti-6Al-4V ELI
(ASTM F136-13) | Stainless Steel
(ASTM F899-20) |
| Principle of
Operation | The Abutment Screw is used for connecting the Angled Abutment to the Fixture, and Healing Cap, Temporary Cylinder, EZ Post Cylinder, Gold Cylinder, CCM Cylinder to the Octa Abutment. | The Octa Abutment Screw is used for connecting the Healing Cap, Temporary Cylinder, EZ Post Cylinder, Gold Cylinder, CCM Cylinder to the Octa Abutment. | The Multi-unit Abutment Screw is used for connecting Multi-unit Abutment to the fixture. | Surface
Treatment | Partial TiN coating | Machined | Machined | Partial TiN coating | Partial TiN coating |
| Single Use | Yes | Yes | Yes | Yes | Yes | | | | |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile | | | | |
1. Similarities
The subject device has the same characteristic for the followings compared to the reference devices.
Indication for use, Design, Connection Interface, Material, Surface Treatment, Single Use, Sterilization and Principle l of Operation.
2. Differences
The subject device has the different characteristic for the followings compared to the reference devices.
Diameter & Total Length -
The dimension of subject device is slightly different with reference devices, but the half are same as reference device 1, and the other half are lie within combined range of reference device 1&2. Also, it does not cause a matter in substantial equivalence since the size difference is very minor.
3. Discussion
Some of the proposed Abutment Screw had been FDA cleared under K123988 with product name of 'Octa Abutment -Screw', but it is being submitted to change their identifier with modification of product name only, and to add a new dimension. Therefore, the proposed Abutment Screw and reference device have common in all the items in the comparison chart except the Diameter and Total Length. These size differences are explained not affecting on the substantial equivalence.
On the basis of the discussion above, it is concluded that the substantially equivalent to the reference device.
36
Meg-Loc Abutment
37
| Principle of Operation | The Meg-Loc Abutment is generally applied to prosthetic procedure for overdentures. The head part is where connected to overdenture with attachment and the screw part is connected directly to the endosseous dental implant by their threaded part. | The Meg-Loc Abutment is generally applied to prosthetic procedure for overdentures. The head part is where connected to overdenture with attachment and the screw part is connected directly to the endosseous dental implant by their threaded part. | The Meg-Rhein Abutment is generally applied to prosthetic procedure for overdentures. The head part is where connected to overdenture with attachment and the screw part is connected directly to the endosseous dental implant by their threaded part. | The Port Abutment is generally applied to prosthetic procedure for overdentures. The head part is where connected to overdenture with attachment and the screw part is connected directly to the endosseous dental implant by their threaded part. | The Meg-Magnet Abutment is generally applied to prosthetic procedure for overdentures. The head part is where connected to overdenture with attachment and the screw part is connected directly to the endosseous dental implant by their threaded part. |
|---|---|---|---|---|---|
| ------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Substantial Equivalence Discussion
1. Similarities
The subject device has the same characteristic for the followings compared to the reference devices.
Indication for use, Design, Diameter, Post Height, Angulation, Connection Interface, Material, Single Use, Sterilization and Principle of Operation.
2. Differences
The subject device has the different characteristic for the followings compared to the reference devices.
Total Length and Gingival (Cuff) Height Almost all the total lengths and cuff height of subject device are same with the reference device 1. The only difference is that slight longer length(13.95mm) and cuff height(6.8mm) is added in the subject device but it is a very slight difference(0.5mm) between the longest length(13.9mm) of reference device2, and all the cuff height of subject device lie within combined range of reference device 1~4. The difference in cuff height is acceptable for the subject device as it is intended to be used with a tissue level implant, with a portion of the cuff height built into the implant, whereas the predicate device is intended to be used with a bone level implant which requires a cuff height for all abutments. Surface Treatment
The subject device is treated with partial Tin Coating in upper part while the reference device 1 is not applicable, but has same surface treatment as reference device 4 and Megagen's FDA cleared reference device 3.
3. Discussion
Some of the proposed Meg-Loc Abutment had been FDA cleared with K192614, but it is being submitted to change their identifier with modification of surface treatment, compatible implant system(ExFeel Internal→AnyOne Onestage), and to add a new dimension. Therefore, the proposed Meg-Loc Abutment and reference device have common in all the items in the comparison chart except the Total Length, Gingival (Cuff) Height and Surface Treatment. These differences are explained not affecting on the substantial equivalence.
This abutment can be used to correct divergence up to the angulation stated. The fatigue testing presented in this submission for the Angled Abutment was leveraged for the fatigue testing of this device. The Angled Abutment is considered an acceptable worse case for fatigue testing because it, the Meg-Loc abutments are all made of the same material, the Angled Abutment has a higher Angulation, and the Angled Abutment presents a higher moment arm than the overdenture type abutments.
On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference device.
38
Meg-Ball Abutment
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) No. | K210161 | K192614 | K182091 |
| Device Name | |||
| (Compatible | |||
| Implant | |||
| System) | Meg-Ball Abutment | ||
| For AnyOne Onestage Implant | |||
| System | Meg-Ball Abutment | ||
| For ExFeel Dental Implant System | Port Abutment | ||
| For TS SA, SS SA, US SA, MS SA | |||
| Implant | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Osstem Implant Co., Ltd. |
| Indications | |||
| for Use | |||
| Statement | The AnyOne Onestage Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or mandibular | |||
| arches for the purpose of providing | |||
| prosthetic support for dental | |||
| restorations (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used to | |||
| restore a patient's chewing function | |||
| in the following situations and with | |||
| the clinical protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and with | |||
| appropriate occlusal loading. Larger | |||
| implants are dedicated for the molar | |||
| region. | Meg-Ball Attachment System, Meg- | ||
| Loc Abutment, Meg-Magnet | |||
| Abutment is intended to be used in | |||
| the upper or lower jaw and used for | |||
| supporting tooth replacements to | |||
| restore chewing function. Intended | |||
| for fully edentulous jaw retaining a | |||
| tissue supported overdenture. | |||
| The abutments in combination with | |||
| endosseous implants are used as the | |||
| foundation for anchoring tooth | |||
| replacements in either jaw. The | |||
| attachments are used in fixed | |||
| overdenture restorations that can be | |||
| attached with a snap-in system. | Osstem Abutment System is intended | ||
| for use with a dental implant to | |||
| provide support for prosthetic | |||
| restorations such as crowns, bridges, | |||
| or overdentures. | |||
| Design | Image: Subject Device Design | Image: Reference Device 1 Design | Image: Reference Device 2 Design |
| Head | |||
| Diameter (Ø) | 2.25 mm | 2.25 mm | N/A |
| Head Height | |||
| (Post Height) | 4.15 mm | 4.15 mm | Unknown |
| Diameter (Ø) | 3.5 mm | 3.5 mm | 3.5, 3.7, 4.1, 4.8, 5.1 mm |
| Total Length | 10.1, 10.6, 11.6, 12.6, 13.6, 14.6, | ||
| 15.6, 16.6 mm | 10.1, 10.6, 11.6, 12.6, 13.6, 14.6, | ||
| 15.6 mm | Unknown | ||
| Gingival | |||
| Height | 0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8, | ||
| 6.8mm | 0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8 mm | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 mm | |
| Angulation | Up to 15° | Up to 15° | Straight |
| Connection | |||
| Interface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) |
| Surface | |||
| Treatment | Machined | Machined | Partial TiN coating |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle of | |||
| Operation | The Meg-Ball Abutment is | ||
| generally applied to prosthetic | |||
| procedure for overdentures. The | |||
| head part is where connected to | |||
| overdenture with attachment | |||
| and the screw part is connected | |||
| directly to the endosseous dental | |||
| implant by their threaded part. | The Meg-Ball Abutment is | ||
| generally applied to prosthetic | |||
| procedure for overdentures. The | |||
| head part is where connected to | |||
| overdenture with attachment | |||
| and the screw part is connected | |||
| directly to the endosseous dental | |||
| implant by their threaded part. | The Port Abutment is generally | ||
| applied to prosthetic procedure | |||
| for overdentures. The head part is | |||
| where connected to overdenture | |||
| with attachment and the screw | |||
| part is connected directly to the | |||
| endosseous dental implant by | |||
| their threaded part. | |||
| Substantial Equivalence Discussion | |||
| 1. Similarities | |||
| The subject device has the same characteristic for the followings compared to the reference devices. | |||
| Indication for use, Design, Head Diameter, Head Length (Post Height), Diameter, Angulation, Connection Interface, | |||
| Material, Surface Treatment, Single Use, Sterilization and Principle of Operation. |
- Differences
The subject device has the different characteristic for the followings compared to the reference devices.
Total Length and Gingival (Cuff) Height | | | |
difference is that slight longer length(16.6mm) and cuff height(6.8mm) is added in the subject device, but the difference in cuff height is acceptable for the subject device as it is intended to be used with a tissue level implant, with a portion of the cuff height built into the implant, whereas the predicate device is intended to be used with a bone level implant which requires a cuff height for all abutments, and all the cuff height of subject device lie within combined range of reference device 1&2.
39
3. Discussion
Some of the proposed Meg-Ball Abutment had been FDA cleared with K192614, but it is being submitted to change their identifier with modification of, compatible implant system(ExFeel Internal→AnyOne Onestage), and to add a new dimension. Therefore, the proposed Meg-Ball Abutment and reference device have common in all the items in the comparison chart except the Total Length and Gingival (Cuff) Height. These size differences are explained not affecting on the substantial equivalence. This abutment can be used to correct divergence up to the angulation stated. The fatigue testing presented in this submission for the Angled Abutment was leveraged for the fatigue testing of this device. The Angled Abutment is considered an acceptable worse case for fatigue testing because it, the Meg-Loc abutments are all made of the same material, the Angled Abutment has a higher Angulation, and the Angled Abutment presents a higher moment arm than the overdenture type abutments.
On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference device.
40
Meg-Magnet Abutment
| Subject Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | |
|---|---|---|---|---|
| 510(k) No. | K210161 | K192614 | K192614 | K182091 |
| Device Name | ||||
| (Compatible | ||||
| Implant | ||||
| System) | Meg-Magnet Abutment | |||
| For AnyOne Onestage | ||||
| Implant System | Meg-Magnet Abutment | |||
| For ExFeel Dental Implant | ||||
| System | Meg-Loc Abutment | |||
| AnyRidge, AnyOne, | ||||
| AnyRidge Octa 1, ExFeel | ||||
| Internal Implant System | Port Abutment | |||
| For TS SA, SS SA, US SA, MS | ||||
| SA Implant | ||||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Osstem Implant Co., Ltd. |
| Indications | ||||
| for Use | ||||
| Statement | The AnyOne Onestage | |||
| Implant System is intended | ||||
| to be surgically placed in | ||||
| the maxillary or mandibular | ||||
| arches for the purpose of | ||||
| providing prosthetic | ||||
| support for dental | ||||
| restorations (Crown, | ||||
| bridges, and overdentures) | ||||
| in partially or fully | ||||
| edentulous individuals. It is | ||||
| used to restore a patient's | ||||
| chewing function in the | ||||
| following situations and | ||||
| with the clinical protocols: | ||||
| -Delayed loading. | ||||
| -Immediate loading when | ||||
| good | ||||
| primary stability is achieved | ||||
| and with appropriate | ||||
| occlusal loading. Larger | ||||
| implants are dedicated for | ||||
| the molar region. | Meg-Ball Attachment | |||
| System, Meg-Loc | ||||
| Abutment, Meg-Magnet | ||||
| Abutment is intended to be | ||||
| used in the upper or lower | ||||
| jaw and used for | ||||
| supporting tooth | ||||
| replacements to restore | ||||
| chewing function. Intended | ||||
| for fully edentulous jaw | ||||
| retaining a tissue supported | ||||
| overdenture. | ||||
| The abutments in | ||||
| combination with | ||||
| endosseous implants are | ||||
| used as the foundation for | ||||
| anchoring tooth | ||||
| replacements in either jaw. | ||||
| The attachments are used | ||||
| in fixed overdenture | ||||
| restorations that can be | ||||
| attached with a snap-in | ||||
| system. | Meg-Ball Attachment | |||
| System, Meg-Loc | ||||
| Abutment, Meg-Magnet | ||||
| Abutment is intended to be | ||||
| used in the upper or lower | ||||
| jaw and used for | ||||
| supporting tooth | ||||
| replacements to restore | ||||
| chewing function. Intended | ||||
| for fully edentulous jaw | ||||
| retaining a tissue supported | ||||
| overdenture. | ||||
| The abutments in | ||||
| combination with | ||||
| endosseous implants are | ||||
| used as the foundation for | ||||
| anchoring tooth | ||||
| replacements in either jaw. | ||||
| The attachments are used | ||||
| in fixed overdenture | ||||
| restorations that can be | ||||
| attached | ||||
| with a snap-in system. | Osstem Abutment System | |||
| is intended for use with a | ||||
| dental implant to provide | ||||
| support for prosthetic | ||||
| restorations such as | ||||
| crowns, bridges, or | ||||
| overdentures. | ||||
| Design | ||||
| Diameter (Ø) | 4.5, 5.0 mm | 4.5, 5.0 mm | 3.89 mm | 3.5, 3.7, 4.1, 4.8, 5.1 mm |
| Total Length | 6.20, 6.25, 6.75, 7.20, | |||
| 7.75, 8.20, 8.75, 9.20, | ||||
| 9.75, 10.20, 10.75, | ||||
| 11.20, 11.75, 12.20, | ||||
| 12.75 mm | 6.20, 6.75, 7.20, 7.75, | |||
| 8.20, 8.75, 9.20, 9.75, | ||||
| 10.20, 10.75, 11.20, | ||||
| 11.75 mm | 6.85, 7.35, 7.45, 7.95, 8, | |||
| 8.1, 8.35, 8.5, 8.6, 8.95, | ||||
| 9.35, 9.5, 9.6, 9.95, | ||||
| 10.35, 10.5, 10.6, 10.95, | ||||
| 11.35, 11.5, 11.6, 11.95, | ||||
| 12.35, 12.5, 12.6, 12.95, | ||||
| 13.5, 13.6 mm | Unknown | |||
| Gingival | ||||
| Height | 0.3, 0.8, 1.8, 2.8, 3.8, | |||
| 4.8, 5.8, 6.8mm | 0.3, 0.8, 1.8, 2.8, 3.8, | |||
| 4.8, 5.8 mm | 0.3, 0.8, 1.8, 2.8, 3.8, | |||
| 4.8, 5.8 mm | 1.0, 2.0, 3.0, 4.0, 5.0, | |||
| 6.0, 7.0 mm | ||||
| Angulation | ||||
| Connection | Straight | |||
| Internal Conical | Straight | |||
| Internal Conical | Straight | |||
| Internal Conical | Straight | |||
| Internal Conical | ||||
| Interface | Connection | Connection | Connection | Connection |
| Material | Stainless Steel | |||
| (ASTM F899-20) | Stainless Steel | |||
| (ASTM F899-20) | Ti-6Al-4V ELI | |||
| (ASTM F136-13) | Ti-6Al-4V ELI | |||
| (ASTM F136-13) | ||||
| Surface | ||||
| Treatment | Partial TiN coating | Partial TiN coating | Machined | Partial TiN coating |
| Single Use | Yes | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Principle of | ||||
| Operation | The | |||
| Meg-Magnet | ||||
| Abutment is generally | ||||
| applied to prosthetic | ||||
| procedure | ||||
| for | ||||
| overdentures. The head | ||||
| part is where connected | ||||
| to | ||||
| overdenture with | ||||
| attachment | ||||
| and the | ||||
| screw part is connected | ||||
| directly | ||||
| to | ||||
| the | ||||
| endosseous | ||||
| dental | ||||
| implant by their | ||||
| threaded part. | The | |||
| Meg-Magnet | ||||
| Abutment is generally | ||||
| applied to prosthetic | ||||
| procedure | ||||
| for | ||||
| overdentures. The head | ||||
| part is where connected | ||||
| to | ||||
| overdenture with | ||||
| attachment | ||||
| and the | ||||
| screw part is connected | ||||
| directly | ||||
| to | ||||
| the | ||||
| endosseous | ||||
| dental | ||||
| implant by their | ||||
| threaded part. | The Meg-Loc Abutment | |||
| is generally applied to | ||||
| prosthetic procedure for | ||||
| overdentures. The head | ||||
| part is where connected | ||||
| to | ||||
| overdenture with | ||||
| attachment | ||||
| and the | ||||
| screw part is connected | ||||
| directly to the | ||||
| endosseous dental | ||||
| implant by their | ||||
| threaded part. | The Port Abutment is | |||
| generally applied to | ||||
| prosthetic procedure for | ||||
| overdentures. The head | ||||
| part is where connected | ||||
| to overdenture with | ||||
| attachment and the | ||||
| screw part is connected | ||||
| directly to the | ||||
| endosseous dental | ||||
| implant by their | ||||
| threaded part. |
41
Substantial Equivalence Discussion
1. Similarities
- The subject device has the same characteristic for the followings compared to the reference devices.
- Indication for use, Design, Diameter, Angulation Interface, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation.
2. Differences
The subject device has the different characteristic for the followings compared to the reference devices.
Total Length and Gingival (Cuff) Height
Almost all the total lengths and cuff height of subject device are same with the reference device 1. The only difference is that slight longer length (6.25, 12.2, 12.75 mm) and cuff height(6.8mm) is added in the subject device, but all the dimensions lie within combined range of reference device 1&2. The difference in cuff height is acceptable for the subject device as it is intended to be used with a tissue level implant, with a portion of the cuff height built into the implant, whereas the predicate device is intended to be used with a bone level implant which requires a cuff height for all abutments.
3. Discussion
Some of the proposed Meg-Magnet Abutment had been FDA cleared with K192614, but it is being submitted to
change their identifier with modification of, compatible implant system(ExFeel Internal→AnyOne Onestage), and to add a new dimension. Therefore, the proposed Meg-Magnet Abutment and reference device have common in all the items in the comparison chart except the Total Length and Gingival (Cuff) Height. These size differences are explained not affecting on the substantial equivalence. Also, the additional fatigue testing is not considered based on FDA Guidance Document being as proposed abutment is straight type. The subject abutment is intended for straight implantation, and is not received single load, because it used for supporting that means load is dispersed to the full denture. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference device.
42
Magnet
:
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) No. | K210161 | K192614 | K192614 |
| Device Name | |||
| (Compatible Implant | |||
| System) | Magnet | ||
| For AnyOne Onestage Implant | |||
| System | Metal Housing | ||
| AnyRidge Internal Implant | |||
| System, AnyOne Internal Implant | |||
| System, AnyRidge Octa 1 Implant | |||
| System | Meg-Magnet Abutment | ||
| For | |||
| AnyRidge, AnyOne, AnyRidge | |||
| Octa 1, ExFeel Internal Implant | |||
| System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for Use | |||
| Statement | The AnyOne Onestage Implant | ||
| System is intended to be | |||
| surgically placed in the maxillary | |||
| or mandibular arches for the | |||
| purpose of providing prosthetic | |||
| support for dental restorations | |||
| (Crown, bridges, and | |||
| overdentures) in partially or fully | |||
| edentulous individuals. It is used | |||
| to restore a patient's chewing | |||
| function in the following | |||
| situations and with the clinical | |||
| protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal loading. | |||
| Larger implants are dedicated for | |||
| the molar region. | Meg-Ball Attachment System, | ||
| Meg-Loc Abutment, Meg-Magnet | |||
| Abutment is intended to be used | |||
| in the upper or lower jaw and | |||
| used for supporting tooth | |||
| replacements to restore chewing | |||
| function. Intended for fully | |||
| edentulous jaw retaining a tissue | |||
| supported overdenture. The | |||
| abutments in combination with | |||
| endosseous implants are used as | |||
| the foundation for anchoring | |||
| tooth replacements in either jaw. | |||
| The attachments are used in fixed | |||
| overdenture restorations that | |||
| can be attached with a snap-in | |||
| system. | Meg-Ball Attachment System, | ||
| Meg-Loc Abutment, Meg-Magnet | |||
| Abutment is intended to be used | |||
| in the | |||
| upper or lower jaw and used for | |||
| supporting tooth replacements to | |||
| restore chewing function. | |||
| Intended for fully edentulous jaw | |||
| retaining a tissue supported | |||
| overdenture. | |||
| The abutments in combination | |||
| with endosseous implants are | |||
| used as the foundation for | |||
| anchoring tooth | |||
| replacements in either jaw. The | |||
| attachments are used in fixed | |||
| overdenture restorations that | |||
| can be attached | |||
| with a snap-in system. | |||
| Design | Image: [design] | Image: [design] | Image: [design] |
| Diameter (Ø) | 4.5, 5.0 mm | 5.0 mm | 4.5, 5.0 mm |
| Total Length | 2.2 mm | 4.0 mm | 5.65, 5.85, 6.15, 6.2, 6.75, 6.8, |
| 6.9, 7.15, 7.2, 7.3, 7.4, 7.75, | |||
| 8.15, 8.2, 8.3, 8.4, 8.75, 9.15, | |||
| 9.2, 9.3, 9.4, 9.75, 10.15, 10.2, | |||
| 10.3, 10.4, 10.75, 11.2, 11.3, | |||
| 11.4, 11.75 mm | |||
| Material | Stainless Steel | ||
| (ASTM F899-20) | Ti-6Al-4V ELI (ASTM F136-13) | Stainless Steel | |
| (ASTM F899-20) | |||
| Surface Treatment | TiN coating | Machined | TiN coating |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle of Operation | The Magnet is generally | ||
| applied to prosthetic | |||
| procedure for overdentures. It | |||
| is inserted and fixed into | |||
| denture; and applied to Meg- | |||
| Magnet Abutment to stabilize | |||
| the overdenture using its | |||
| magnetic force. | The Metal housing is generally | ||
| applied to prosthetic | |||
| procedure for overdentures. | |||
| It is inserted and fixed into | |||
| denture; and applied to ball | |||
| type abutment to stabilize the | |||
| overdenture. | The Meg-Magnet Abutment is | ||
| generally applied to prosthetic | |||
| procedure for overdentures. | |||
| The head part is where | |||
| connected to overdenture | |||
| with attachment and the | |||
| screw part is connected | |||
| directly to the endosseous | |||
| dental implant by their | |||
| threaded part. | |||
| Substantial Equivalence Discussion | |||
| 1. Similarities | |||
| The subject device has the same characteristic for the followings compared to the reference devices. | |||
| Indication for use, Design, Single Use, Sterilization and Principle of Operation | |||
| 2. Differences | |||
| The subject device has the different characteristic for the followings compared to the reference devices. | |||
| Diameter, Total Length |
- The dimension of subject device is slightly different with reference device 1, but it is due to the difference of
compatible abutment. Also, it does not cause a matter in substantial equivalence since the size difference is very
minor.
Material, Surface Treatment - The material and surface treatment of subject device is different with reference device 1, but has made with same
material and surface treatment with reference device 2. | | | |
43
3. Discussion
The proposed Magnet and reference device 1 have common in all the items in the comparison chart except the 1 Diameter, Total Length, Material and Surface Treatment. These differences are not affecting on the substantial equivalence since the variety of the size can be possible to operate more precise treatment to meet each patient's condition and the material and surface treatment same as MegaGen's reference device 2. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference device.
44
Meg-Rhein Abutment
| Subject Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | |
|---|---|---|---|---|
| 510(k) No. | K210161 | K150537 | K182091 | K192614 |
| Device Name | ||||
| (Compatible | ||||
| Implant | ||||
| System) | Meg-Rhein Abutment | |||
| For AnyOne Onestage | ||||
| Implant System | Meg-Rhein Abutment | |||
| For MiNi Internal Implant | ||||
| System | Port Abutment | |||
| For TS SA, SS SA, US SA, MS | ||||
| SA Implant | Meg-Magnet Abutment | |||
| For AnyRidge, AnyOne, | ||||
| AnyRidge Octa 1, ExFeel | ||||
| Internal Implant System | ||||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Osstem Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications | ||||
| for Use | ||||
| Statement | The AnyOne Onestage | |||
| Implant System is intended | ||||
| to be surgically placed in | ||||
| the maxillary or mandibular | ||||
| arches for the purpose of | ||||
| providing prosthetic | ||||
| support for dental | ||||
| restorations (Crown, | ||||
| bridges, and overdentures) | ||||
| in partially or fully | ||||
| edentulous individuals. It is | ||||
| used to restore a patient's | ||||
| chewing function in the | ||||
| following situations and | ||||
| with the clinical protocols: | ||||
| -Delayed loading. | ||||
| -Immediate loading when | ||||
| good | ||||
| primary stability is achieved | ||||
| and with appropriate | ||||
| occlusal loading. Larger | ||||
| implants are dedicated for | ||||
| the molar region. | The MiNi Internal Implant | |||
| System is intended for two- | ||||
| stage surgical procedures in | ||||
| the following situations and | ||||
| with the following clinical | ||||
| protocols: |
- The intended use for the
3.0 mm diameter MiNi
implant is limited to the
replacement of
maxillary lateral incisors
and mandibular incisors. - Immediate placement in
extraction sites and in
situations with a partially or
completely
healed alveolar ridge. - It is intended for delayed
loading. | Osstem Abutment System
is intended for use with a
dental implant to provide
support for prosthetic
restorations such as
crowns, bridges, or
overdentures. | Meg-Ball Attachment
System, Meg-Loc
Abutment, Meg-Magnet
Abutment is intended to be
used in the upper or lower
jaw and used for
supporting tooth
replacements to restore
chewing function. Intended
for fully edentulous jaw
retaining a tissue supported
overdenture.
The abutments in
combination with
endosseous implants are
used as the foundation for
anchoring tooth
replacements in either jaw.
The attachments are used
in fixed overdenture
restorations that can be
attached with a snap-in
system. |
| Design | | | | |
| Head
Diameter (Ø) | 2.5mm | 2.5 mm | Unknown | N/A |
| Head Height
(Post Height) | 1.7 mm | 1.5, 1.7 mm | Unknown | N/A |
| Diameter (Ø) | 3.5 mm | 3.0, 3.1, 3.4 mm | 3.5, 3.7, 4.1, 4.8, 5.1 mm | 4.5, 5.0mm |
| Total Length | 7.45, 9.15, 11.15, 13.15
mm | 6.55, 6.95, 7.25, 7.75,
7.95, 8.40, 8.75, 8.90,
8.95, 9.75, 9.90, 9.95,
10.75, 10.90, 10.95,
11.75, 11.90, 11.95,
12.75, 12.90, 13.90 mm | Unknown | 5.65, 5.85, 6.15, 6.2,
6.75, 6.8, 6.9, 7.15, 7.2,
7.3, 7.4, 7.75, 8.15, 8.2,
8.3, 8.4, 8.75, 9.15, 9.2,
9.3, 9.4, 9.75, 10.15
10.2, 10.3, 10.4, 10.75,
11.2, 11.3, 11.4, 11.75
mm |
| Gingival
Height | 0.3, 2.0, 4.0, 6.0 mm | 0.2, 0.3, 1.0, 2.0, 3.0,
4.0, 5.0, 6.0 mm | 1.0, 2.0, 3.0, 4.0, 5.0,
6.0, 7.0 mm | 0.3, 0.8, 1.8, 2.8, 3.8,
4.8, 5.8mm |
| Angulation | Straight | Straight | Straight | Straight |
| Connection | Internal Conical | Internal Conical | Internal Conical | Internal Conical |
| Interface | Connection | Connection | Connection | Connection |
| Material | Ti-6Al-4V ELI
(ASTM F136-13) | Ti-6Al-4V ELI
(ASTM F136-13) | Ti-6Al-4V ELI
(ASTM F136-13) | Stainless Steel
(ASTM F899-20) |
| Surface
Treatment | Partial TiN coating | Machined | Partial TiN coating | Partial TiN coating |
| Single Use | Yes | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Principle of
Operation | The
Meg-Rhein
Abutment is generally
to prosthetic
applied
procedure
tor
overdentures. The head
part is where connected
overdenture
with
to
attachment
and
the
screw part is connected
directly
to
the
endosseous
dental
implant
by
their
threaded part. | The
Meg-Rhein
Abutment is generally
to prosthetic
applied
procedure
tor
overdentures. The head
part is where connected
overdenture
to
with
attachment
and
the
screw part is connected
directly
to
the
endosseous
dental
implant
by
their
threaded part. | The Port Abutment is
generally applied
to
prosthetic procedure for
overdentures. The head
part is where connected
overdenture
to
with
attachment
and
the
screw part is connected
directly
to
the
dental
endosseous
implant
by
their
threaded part. | Meg-Magnet
The
Abutment is generally
applied to prosthetic
procedure
tor
overdentures. The head
part is where connected
overdenture
with
to
attachment
and
the
screw part is connected
directly
to
the
endosseous
dental
implant
by
their
threaded part. |
45
Substantial Equivalence Discussion 1. Similarities The subject device has the same characteristic for the followings compared to the reference devices. Indication for use, Design, Head Diameter, Head Height (Post Height), Gingival (Cuff) Height, Angulation, Connection Interface, Material, Single Use, Sterilization and Principle of Operation. 2. Differences The subject device has the different characteristic for the followings compared to the reference devices. Diameter and Total Length The diameter and total length of subject device is slightly different with reference device 1, but it lies within combined range of reference devices 1~3. The difference in cuff height is acceptable for the subject device as it is intended to be used with a tissue level implant, with a portion of the cuff height built into the implant, whereas the predicate device is intended to be used with a bone level implant which requires a cuff height for all abutments. -Surface Treatment The subject device is treated with partial Tin Coating in upper part while the reference device 1 is not applicable, but has same surface treatment as reference device 2 and Megagen's FDA cleared reference device 3. 3. Discussion The proposed Meg-Rhein Abutment is being submitted to add in Megager's existing prothein had
been FDA cleared. Therefore, the proposed Meg-Rhein Abutment and reference device items in the comparison chart except the Diameter, Total Length and Surface Treatment. These differences are explained not affecting on the substantial equivalence. Also, the additional fatigue testing is not considered based on FDA Guidance Document being as proposed abutment is straight type. The subject abutment is intended for straight implantation, and is not received single load, because it used for supporting that means
load is dispersed to the full denture. On the basis of the discussion above, it is concluded that the subject device is
substantially equivalent to the reference device.
46
Summary of Non-Clinical Testing 8.
The non-clinical testing data which are submitted, referenced, or relied on in this submission support demonstrating substantial equivalence.
Biocompatibility
The biocompatibility evaluation has been performed in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
The additional biocompatibility testing is not required on the AnyOne Onestage Implant System since AnyOne Onestage Implant System has same material composition, manufacturing process and patient contacting parts as predicate device, AnyRidge Octa 1 Implant System (K182448), ExFeel Dental Implant System (K052369), AnyOne Internal Implant System (K123988) and Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment (K19614).
Modified Surface Treatment
The surface treatment evaluation has been performed in accordance with 'Section 11 of Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'.
AnyOne Onestage Implant System has same surface treatment and manufacturing process as predicate device, AnyRidge Octa 1 Implant System (K182448) and ExFeel Dental Implant System (K052369) for the surface treatment of S.L.A and Anodizing, and Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment (K19614) for TiN coating.
Pyrogen and Endotoxin Test
The subject device will not be labeled as "non-pyrogenic", and the endotoxin testing will be conducted on every batch for the subject device with the testing limit of below 0.5 EU/mL in accordance with the USP 39 .
Sterilization validation
Sterilization validating testing has been performed in accordance with ISO 11137 and ISO 17665-1, 2 to verify the sterility assurance level (104). The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980 and the test results validated 5 years shelf life.
Also, the following guidance documents were referred to:
- . Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Performance (Physical Properties) Test
The following bench tests have been performed in accordance with "ISO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment" to evaluate the performance of the subject devices and the test results met the pre-set criteria.
- . Static compression-strength test
- . Fatigue test
9. Summary of Clinical Testing
No clinical studies are submitted.
10. Conclusion
Based on the information provided in this premarket notification, We, MegaGen Implant Co., Ltd. conclude that the AnyOne Onestage Implant System is substantially equivalent to the predicate device as herein.