(267 days)
No
The summary describes a standard dental implant system and does not mention any AI or ML components or functionalities.
Yes
The device is described as "surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations" and "used to restore a patient's chewing function", which falls under the definition of a therapeutic device as it treats or restores a medical condition (lost chewing function due to edentulism).
No
The device description indicates that the "AnyOne External Implant System is an integrated system of endosseous dental implants" used to support prosthetic devices for dental restorations and restore chewing function. It does not mention any function related to diagnosing a condition or disease.
No
The device description clearly states it is an integrated system of endosseous dental implants consisting of fixtures and abutments made of physical materials (CP Ti Grade 4, Ti-6A1-4V ELI, Gold alloy, CCM alloy). It is surgically placed, indicating a physical hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical placement in the jawbone to support dental restorations and restore chewing function. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The description details the physical components of the implant system (fixtures and abutments) and their materials. It describes a physical device implanted into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
The device is a medical device, specifically a dental implant system, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AnyOne External 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
AnyOne External 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 External 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. Dental prosthesis is a superstructure of a dental implant system and connecting elements between the dental implant and the crown. It is made of Ti-6A1-4V ELI, Gold alloy, CCM alloy and intended to be placed on the fixture allows single & multiple prosthetic 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 molar areas
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 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
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.
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, K123988, K192347, K053353, K182448, K150537, K192436, K110955, K081302, K160670, K171142, K182091, K192614
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
MegaGen Implant Co., Ltd. % You Jung Kim Chief Researcher DaeGyeong Regulatory Affairs Institute 32, Innovalley-ro Daegu, Dong-gu 41065 REPUBLIC OF KOREA
Re: K203554
Trade/Device Name: AnyOne External Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 30, 2021 Received: July 30, 2021
Dear You Jung 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)
Device Name
AnyOne External Implant System
The AnyOne External 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The- |
e-Counter Use (21 CFR 801 Subpart C)
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3
K203554
510(k) Summary
Date: August 28, 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 Fax: +82-53-247-2254 Tel: +82-53-247-2258 Email: ra3@dgri.co.kr
3. Device
| ▪ Trade Name: | AnyOne External 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:
K122231 - Xpeed AnyRidge Internal Implant System
. Reference Devices:
- K052369 ExFeel Dental Implant System
- K123988 AnyOne Internal Implant System
- K192347 ST Internal Implant System
- K053353 Rescue Dental Implant System
- K182448- AnyRidge Octa 1 Implant System
- K150537 MiNi Internal Implant System
- K192436 Healing Abutments and Cover Screws
- K110955 AnyRidge Internal Implant System
- K081302 Rescue External Implant System
- K160670 ET US SS Prosthetic System
- K171142 Healing Cap Multi-Unit Titanium
- K182091 Osstem Abutment System
K192614 - Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment
4
5. Description
- . AnyOne External 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 External 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. Dental prosthesis is a superstructure of a dental implant system and connecting elements between the
dental implant and the crown. It is made of Ti-6A1-4V ELI, Gold alloy, CCM alloy and intended to be placed on the fixture allows single & multiple prosthetic restore a patient's chewing function.
| Content | |||
|---|---|---|---|
| 1. Fixture | AnyOne | ||
| External | |||
| Fixture | Description | AnyOne External Fixture is a substructure of a dental | |
| implant system made of titanium and have the interface | |||
| connection for External Hex. 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 | |||
| $Ø$ 5.8 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm | |||
| $Ø$ 6.3 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm | |||
| $Ø$ 6.8 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm | |||
| 2. Cover | |||
| Screw | |||
| & | |||
| Healing | |||
| Abutment | 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-6A1-4V ELI (ASTM F136-13) | ||
| Dimension | |||
| (Diameter & Length) | $Ø$ 3.5 x 5.3, 6.2 mm | ||
| $Ø$ 4.1 x 5.3, 6.2 mm | |||
| $Ø$ 5.0 x 5.3, 6.2 mm | |||
| Gingival (Cuff) Heights | 1.3 mm | ||
| Angulation | Straight |
- . The proposed AnyOne External 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
| Screw
&
Healing
Abutment | Screw | | protecting the inner structure of a fixture, and exposed
fixture platform after fixture placement. |
|-----------------------------------|---------------------------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Healing
Abutment | Material | Ti-6A1-4V ELI (ASTM F136-13) |
| | | Dimension
(Diameter & Length) | Ø 3.5 x 5.3, 6.2 mm
Ø 4.1 x 5.3, 6.2 mm
Ø 5.0 x 5.3, 6.2 mm |
| | | Gingival (Cuff) Heights | 1.3 mm |
| | | Angulation | Straight |
| | | Description | The Healing Abutment is used in conjunction with fixture
and helps to form suitable emergence profile during period
of gingival healing. |
| | Healing
Abutment | Material | Ti-6A1-4V ELI (ASTM F136-13) |
| | | Dimension
(Diameter & Length) | Ø 4.0 x 6.8, 7.7, 7.8, 8.7, 8.8, 9.7, 9.8, 10.7, 11.8, 12.7 mm
Ø 5.0 x 6.8, 7.7, 7.8, 8.7, 8.8, 9.7, 9.8, 10.7, 11.8, 12.7 mm
Ø 6.0 x 6.8, 7.7, 7.8, 8.7, 8.8, 9.7, 9.8, 10.7, 11.8, 12.7 mm
Ø 7.0 x 6.8, 7.7, 7.8, 8.7, 8.8, 9.7, 9.8, 10.7, 11.8, 12.7 mm |
| | | Gingival (Cuff) Heights | 2.0, 3.0, 4.0, 5.0, 7.0 mm |
| | | Angulation | Straight |
| | | Description | The Esthetic Healing Abutment is used in conjunction with
fixture and helps to form suitable emergence profile during
period of gingival healing. It is helpful to maintain more
thickness of soft tissue and easy to make soft tissue closure
against narrow top. |
| | Esthetic
Healing
Abutment | Material | Ti-6A1-4V ELI (ASTM F136-13) |
| | | Dimension
(Diameter & Length) | Ø 3.5 x 6.2, 7.2, 8.2 mm
Ø 4.1 x 6.2, 7.2, 8.2 mm
Ø 5.0 x 6.2, 7.2, 8.2 mm |
| | | Gingival (Cuff) Heights | 2.5, 3.5, 4.5 mm |
| | | Angulation | Straight |
5
| 3. Fixture
Level
Prosthesis | Temporary
Abutment | Description | The Temporary Abutment is used in conjunction with fixture
to provide support for provisional restoration. It is
connected to the Fixture using Abutment Screw. It has a
maximum intra-oral use of 180-days. | | | | |
|-----------------------------------|-----------------------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|----------------------------------|----------------|--|
| | | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | |
| | | Dimension
(Diameter & Length) | Ø 3.9 x 12.0 mm
Ø 4.5 x 12.0 mm
Ø 5.5 x 12.0 mm | | | | |
| | | Post Heights | 10.0 mm | | | | |
| | | Gingival (Cuff) Heights | 1.3 mm | | | | |
| | | Angulation | Straight | | | | |
| | 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 Abutment
Screw. | | | | |
| | | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | |
| | | Dimension
(Diameter & Length) | Ø 4.0 x 10.0, 12.0 mm
Ø 5.0 x 9.0, 10.0, 11.0, 12.0 mm
Ø 6.0 x 9.0, 10.0, 11.0, 12.0 mm | | | | |
| | | Post Heights | 8.0 mm | | | | |
| | | Gingival (Cuff) Heights | 1.0, 2.0, 3.0, 4.0 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-6A1-4V ELI (ASTM F136-13) | | | | |
| | | Dimension
(Diameter & Length) | Ø 4.0 x 9.0, 11.0 mm
Ø 5.0 x 9.0, 11.0 mm
Ø 6.0 x 9.0, 11.0 mm | | | | |
| | | Post Heights | 7.0 mm | | | | |
| | | Gingival (Cuff) Heights | 2.0, 4.0 mm | | | | |
| | | Angulation | 15°, 25° | | | | |
| | Milling
Abutment | Description | The Milling Abutment is used in conjunction with fixture and
used for establishing an adequate safety margin from
occlusal line by hand milling of the post part. It is connected
to the Fixture using Abutment Screw.
(Note. Only be for Hand Milling with no CAD/CAM) | | | | |
| | | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | |
| | | Dimension
(Diameter & Length) | Ø 4.0 x 11.0, 13.0 mm
Ø 5.0 x 10.0, 11.0, 12.0, 13.0 mm
Ø 6.0 x 10.0, 11.0, 12.0, 13.0 mm
Ø 7.0 x 10.0, 11.0, 12.0, 13.0 mm | | | | |
| | | Post Heights | 9.0 mm | | | | |
| | | Gingival (Cuff) Heights | 1.0, 2.0, 3.0, 4.0 mm | | | | |
| | | Angulation | Straight | | | | |
| | 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. It
is connected to the Fixture using Abutment Screw. | | | | |
| | | Material | Body: Gold Alloy / Sleeve: POM | | | | |
| | | Dimension
(Diameter & Length) | Ø 4.0 x 11.0 mm
Ø 4.5 x 11.2 mm
Ø 5.5 x 11.2 mm | | | | |
| | | Post Height | 10.0 mm | | | | |
| | | Gingival (Cuff) Heights | 1.0, 1.2 mm | | | | |
| | | Angulation | Straight | | | | |
| | Abutment
Screw | Description | The Abutment Screw is used for connecting Fixture to
Temporary Abutment, EZ Post Abutment, Angled
Abutment, Milling Abutment or Gold Abutment. | | | | |
| | | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | |
| | | | | Dimension
(Diameter & Length) | Dimension
(Diameter & Length) | Ø 2.5 x 7.5 mm | |
| 4.Abutment
Level
Prosthesis | Regular
Abutment | Description | The Regular Abutment is used in conjunction with fixture
and used for fabrication of either screw or cement retained
prosthetics. It is connected to the Fixture using Regular
Abutment Screw. | | | | |
| | | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | |
| | | Dimension
(Diameter & Length) | Ø 4.5 x 3.0, 4.0, 5.5, 7.0, 8.5 mm
Ø 4.8 x 3.0, 3.8, 4.8, 5.8 mm | | | | |
| | | Post Heights | 1.8 mm | | | | |
6
| Gingival (Cuff) Heights | 1.2, 2.0, 3.0, 4.0 mm | |||
|---|---|---|---|---|
| Angulation | Straight | |||
| Regular | ||||
| Abutment | ||||
| Screw | Description | The Regular Abutment Screw is used for connecting Fixture | ||
| to Regular Abutment. | ||||
| Material | Ti-6A1-4V ELI (ASTM F136-13) | |||
| Dimension | ||||
| (Diameter & Length) | $Ø$ 2.95 x 8.85, 9.85, 10.85, 11.85 mm | |||
| $Ø$ 3.5 x 7.9, 9.05, 10.55, 12.05, 13.55 mm | ||||
| Multi-unit | ||||
| Abutment | Description | The Multi-unit Abutment is used in conjunction with fixture | ||
| to fabricate screw-retained prosthesis. It is two-piece type | ||||
| and connected the fixture with Multi-unit Abutment Screw. | ||||
| Material | Ti-6A1-4V ELI (ASTM F136-13) | |||
| Dimension | ||||
| (Diameter & Length) | $Ø$ 4.8 x 2.0, 3.0, 4.0, 5.0, 6.0 mm | |||
| Post Heights | 1.0 mm | |||
| Gingival (Cuff) Heights | 1.0, 2.0, 3.0, 4.0, 5.0 mm | |||
| Angulation | Straight | |||
| Multi-unit | ||||
| Angled | ||||
| Abutment | Description | The Multi-unit Angled Abutment is used in conjunction with | ||
| fixture for fabricating screw-retained prosthesis and | ||||
| correcting the prosthetic angulation of implant. It is two- | ||||
| piece type and connected the fixture with Multi-unit | ||||
| Abutment Screw. | ||||
| Material | Ti-6A1-4V ELI (ASTM F136-13) | |||
| Dimension | ||||
| (Diameter & Length) | $Ø$ 4.8 x 3.65, 4.65, 5.13, 5.65, 6.13 mm | |||
| Post Heights | 2.2 mm | |||
| Gingival (Cuff) Heights | 2.0, 3.0, 4.0, 5.0 mm | |||
| Angulation | 17°, 30° | |||
| Multi-unit | ||||
| Abutment | ||||
| Screw | Description | The Multi-unit Abutment Screw is used for connecting | ||
| Multi-unit Abutment or Multi-unit Angled Abutment to the | ||||
| fixture. | ||||
| Material | Ti-6A1-4V ELI (ASTM F136-13) | |||
| Dimension | ||||
| (Diameter & Length) | $Ø$ 2.4 x 6.8 mm | |||
| $Ø$ 2.9 x 6.7, 7.7, 8.7, 9.7, 10.7 mm | ||||
| Healing Cap | Description | The Healing Cap is used for protecting Regular Abutment or | ||
| Multi-unit (Angled) Abutment and minimizing irritation to | ||||
| tongue and oral mucosa during period of gingival healing. It | ||||
| is connected to the Abutment using its threaded part or | ||||
| Cylinder Screw. It has a maximum intra-oral use of 180-days. | ||||
| Material | Ti-6A1-4V ELI (ASTM F136-13) | |||
| Dimension | ||||
| (Diameter & Length) | $Ø$ 4.9 x 4.2 mm | |||
| $Ø$ 5.0 x 6.1 mm | ||||
| $Ø$ 6.8 x 4.2 mm | ||||
| Temporary | ||||
| Abutment | Description | The Temporary Abutment is used in conjunction with | ||
| Regular Abutment to provide support for provisional | ||||
| restoration. It is connected to the Abutment using | ||||
| Abutment Screw. It has a maximum intra-oral use of 180- | ||||
| days. | ||||
| Material | Ti-6A1-4V ELI (ASTM F136-13) | |||
| Dimension | ||||
| (Diameter & Length) | $Ø$ 4.8 x 12.35 mm | |||
| Post Heights | 7.5 mm | |||
| Gingival (Cuff) Heights | 2.8 mm | |||
| Temporary | ||||
| Cylinder | Angulation | Straight | ||
| Description | The Temporary Cylinder is used in conjunction with Multi- | |||
| unit (Angled) Abutment to provide support for provisional | ||||
| restoration. It is connected to the Abutment using Cylinder | ||||
| Screw. It has a maximum intra-oral use of 180-days. | ||||
| Material | Ti-6A1-4V ELI (ASTM F136-13) | |||
| Dimension | ||||
| (Diameter & Length) | $Ø$ 4.8 x 12.0 mm | |||
| Post Heights | 8.5 mm | |||
| Gingival (Cuff) Heights | 3.0 mm | |||
| Angulation | Straight | |||
| EZ Post | ||||
| Cylinder | Description | The EZ Post Cylinder is used in conjunction with Regular | ||
| Abutment to provide support for cement and screw type | ||||
| final prosthesis. It is connected to the Abutment using | ||||
| Abutment Screw. | ||||
| Dimension | ||||
| (Diameter & Length) | Material | $\unicode{x2300}$ 5.0 x 8.5 mm | Ti-6A1-4V ELI (ASTM F136-13) | |
| Post Heights | 7.7 mm | |||
| Gingival (Cuff) Heights | 0.8 mm | |||
| Angulation | Straight | |||
| Gold | ||||
| Cylinder | Description | The Gold Cylinder is used in conjunction with Regular | ||
| Abutment to provide support for screw type final prosthesis | ||||
| by casting with precious metal alloy. It is connected to the | ||||
| Abutment using Abutment Screw. | ||||
| Material | Body: Gold Alloy / Sleeve: POM | |||
| Dimension | ||||
| (Diameter & Length) | Ø 4.8 x 13.0 mm | |||
| Post Heights | 10.0 mm | |||
| Gingival (Cuff) Heights | 3.0 mm | |||
| Angulation | Straight | |||
| CCM | ||||
| Cylinder | Description | The CCM Cylinder is used in conjunction with Regular | ||
| Abutment or with Multi-unit (Angled) Abutment to provide | ||||
| support for screw type final prosthesis by casting with non- | ||||
| precious metal alloy. It is connected to the Abutment using | ||||
| Abutment Screw or Cylinder Screw. | ||||
| Material | Body: Co-Cr-Mo Alloy / Sleeve: POM | |||
| Dimension | ||||
| (Diameter & Length) | Ø 4.8 x 13.0, 15.0 mm | |||
| Post Heights | 10.0, 13.0 mm | |||
| Gingival (Cuff) Heights | 2.0, 3.0 mm | |||
| Angulation | Straight | |||
| Description | ||||
| Abutment | ||||
| Screw | The Abutment Screw is used for connecting Regular | |||
| Abutment to Temporary Abutment, EZ Post Cylinder, Gold | ||||
| Cylinder or CCM Cylinder. | ||||
| Material | Ti-6A1-4V ELI (ASTM F136-13) | |||
| Dimension | ||||
| (Diameter & Length) | Ø 2.45 x 4.8 mm | |||
| Cylinder | ||||
| Screw | Description | The Cylinder Screw is used for connecting Multi-unit | ||
| (Angled) Abutment to Healing Cap, Temporary Cylinder or | ||||
| CCM Cylinder. | ||||
| Material | ||||
| Dimension | ||||
| (Diameter & Length) | Ti-6A1-4V ELI (ASTM F136-13) | |||
| Ø 2.0 x 3.4 mm | ||||
| 5. Overdenture | ||||
| Prosthesis | Meg-Rhein | |||
| Abutment | Description | The Meg-Rhein Abutment is used in conjunction with fixture | ||
| and used to restore the patient's masticatory function by | ||||
| supporting the prosthesis such as artificial teeth and is | ||||
| intended to fixate and stabilize the removable denture | ||||
| exactly by connecting fixture and Denture. It is connected to | ||||
| the Fixture using its threaded part. | ||||
| Material | Ti-6A1-4V ELI (ASTM F136-13) | |||
| Dimension | ||||
| (Diameter & Length) | Ø 3.5 x 7.9, 9.9, 11.9 mm | |||
| Ø 4.1 x 7.9, 9.9, 11.9 mm | ||||
| Ø 5.0 x 7.9, 9.9, 11.9 mm | ||||
| Post Heights | 1.7 mm | |||
| Gingival (Cuff) Heights | 2.0, 4.0, 6.0 mm | |||
| Angulation | Straight |
7
8
[Note. 1] Some of devices described in this submission had been FDA cleared with K052369 and K123988, but it is being submitted to change their identifier with modification of product name or material, and to add new dimensions as followings. The changes are explained not affecting substantial equivalence in this 510(k) Submission.
| No. | 510(k) No. | Predicate Device | Subject Device | Change | ||
|---|---|---|---|---|---|---|
| Product Name | Material | Product Name | Material | |||
| 1 | K052369 | Cover Screw | CP Ti Grade 3 | Cover Screw | Ti-6A1-4V ELI | - Material |
- New models
are added |
| 2 | K052369 | Healing
Abutment | CP Ti Grade 3 | Healing Abutment | Ti-6A1-4V ELI | - Material - New models
are added |
| 3 | K052369 | Cement
Abutment | CP Ti Grade 3 | EZ Post Abutment | Ti-6A1-4V ELI | - Material - Product Name |
| 4 | K052369 | UCLA Gold
Abutment | No change | Gold Abutment | No change | - Product Name |
| 5 | K052369 | Coping Screw | No change | Abutment Screw | No change | - Product Name |
| 6 | K052369 | Regular
Abutment | CP Ti Grade 3 | Regular Abutment | Ti-6A1-4V ELI | - Material |
| 7 | K052369 | Regular
Abutment Screw | CP Ti Grade 3 | Regular
Abutment Screw | Ti-6A1-4V ELI | - Material |
| 8 | K052369
K123988 | Healing Cap
Octa Healing Cap | CP Ti Grade 3
Ti-6A1-4V ELI | Healing Cap | Ti-6A1-4V ELI | - Product Name - Material
- New models
are added |
| 9 | K052369
K123988 | Temporary
Cylinder
Temporary
Cylinder | CP Ti Grade 3
CP Ti Grade 4 | Temporary
Abutment | Ti-6A1-4V ELI | - Product Name - Material
- New models
are added |
| 10 | K052369
K123988 | Conical Abutment
EZ Post Cylinder | CP Ti Grade 3
CP Ti Grade 4 | EZ Post Cylinder | Ti-6A1-4V ELI | - Product Name - Material |
| 11 | K052369 | Temporary
(Cylinder) Screw | No change | Abutment Screw | No change | - Product Name |
[Note. 2] The following device described in this submission also had been FDA cleared with K123988, but it is being submitted to change their identifier only without any modification.
| Predicate Device | Subject Device | |||
|---|---|---|---|---|
| No. | 510(k) No. | Product Name | Product Name | Change |
| 1 | K123988 | Gold Cylinder | Gold Cylinder | N/A |
9
6. Indication for use
The AnyOne External 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.
7. Basis for Substantial Equivalence
The AnyOne External 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. Performance test of subject device demonstrated the minor difference in size range did not affect substantial equivalence.
The Indications for Use for the subject devices is identical to the primary predicate, K122231 and the reference device, K123988.
In order to demonstrate the difference in design and size ranges 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'. 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 External Fixture
| Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|---|
| 510(k) No. | K203554 | K122231 | K052369 | K123988 |
| Device Name | ||||
| (Compatible | ||||
| Implant | ||||
| System) | AnyOne External | |||
| Fixture | ||||
| For AnyOne External Implant | ||||
| System | XPEED AnyRidge | |||
| Internal Fixture | ||||
| For Xpeed AnyRidge Internal | ||||
| Implant System | ExFeel External Fixture | |||
| For ExFeel Dental Implant | ||||
| System | AnyOne Internal Fixture | |||
| For AnyOne Internal 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 External | |||
| 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 Xpeed AnyRidge | |||
| 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 fuilly | ||||
| edentulous individuals. | ||||
| It is used to restore a | ||||
| patient's chewing | ||||
| function. Smaller | ||||
| implants (less than 06.0 | ||||
| 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 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 06.0 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 AnyOne External Fixture | Image: Design of XPEED AnyRidge Internal Fixture | Image: Design of ExFeel External Fixture | Image: Design of AnyOne Internal Fixture |
| Diameter (Ø) | ||||
| & | ||||
| Total Length | Ø3.9 x 7.0, 8.0, 9.5, 11.0, | |||
| 12.5, 14.5 mm | ||||
| Ø4.3 x 7.0, 8.0, 9.5, 11.0, | ||||
| 12.5, 14.5 mm | ||||
| Ø4.8 x 7.0, 8.0, 9.5, 11.0, | ||||
| 12.5, 14.5 mm | ||||
| Ø5.3 x 7.0, 8.0, 9.5, 11.0, | ||||
| 12.5, 14.5 mm | ||||
| Ø5.8 x 7.0, 8.0, 9.5, 11.0, | ||||
| 12.5, 14.5 mm | ||||
| Ø6.3 x 7.0, 8.0, 9.5, 11.0, | ||||
| 12.5, 14.5 mm | ||||
| Ø6.8 x 7.0, 8.0, 9.5, 11.0, | ||||
| 12.5, 14.5 mm | Ø4.0 x 7.2, 9.2, 10.7, | |||
| 12.2, 14.2, 17.2 mm | ||||
| Ø4.4 x 7.2, 9.2, 10.7, | ||||
| 12.2, 14.2, 17.2 mm | ||||
| Ø4.9 x 7.2, 9.2, 10.7, | ||||
| 12.2, 14.2, 17.2 mm | ||||
| Ø5.4 x 7.2, 9.2, 10.7, | ||||
| 12.2, 14.2, 17.2 mm | ||||
| Ø5.9 x 7.2, 9.2, 10.7, | ||||
| 12.2, 14.2, 17.2 mm | ||||
| Ø6.4 x 7.9, 9.4, 10.9, | ||||
| 12.4, 14.4 mm | ||||
| Ø6.9 x 7.9, 9.4, 10.9, | ||||
| 12.4, 14.4 mm | ||||
| Ø7.4 x 7.9, 9.4, 10.9, | ||||
| 12.4, 14.4 mm | ||||
| Ø7.9 x 7.9, 9.4, 10.9, | ||||
| 12.4, 14.4 mm | ||||
| Ø8.4 x 7.9, 9.4, 10.9, | ||||
| 12.4, 14.4 mm | Ø3.25 x 8.1, 9.6, 11.1, | |||
| 12.6, 14.6, 17.6 mm | ||||
| Ø3.7 x 8.1, 9.6, 11.1, | ||||
| 12.6, 14.6, 17.6 mm | ||||
| Ø3.95 x 8.1, 9.6 mm | ||||
| Ø4.0 x 11.1, 12.6 14.6, | ||||
| 17.6 mm | ||||
| Ø4.95 x 8.1, 9.6, 11.1, | ||||
| 12.6, 14.6 mm | Ø3.9 x 7.0, 8.0, 9.5, 11.0, | |||
| 12.5, 14.5 mm | ||||
| Ø4.3 x 7.0, 8.0, 9.5, 11.0, | ||||
| 12.5, 14.5 mm | ||||
| Ø4.8 x 7.0, 8.0, 9.5, 11.0, | ||||
| 12.5, 14.5 mm | ||||
| Ø5.3 x 7.0, 8.0, 9.5, 11.0, | ||||
| 12.5, 14.5 mm | ||||
| Ø5.8 x 7.0, 8.0, 9.5, 11.0, | ||||
| 12.5, 14.5 mm | ||||
| Ø6.3 x 7.0, 8.0, 9.5, 11.0, | ||||
| 12.5, 14.5 mm | ||||
| Ø6.8 x 7.0, 8.0, 9.5, 11.0, | ||||
| 12.5, 14.5 mm | ||||
| Ø7.3 x 7.0, 8.0, 9.5, 11.0, | ||||
| 12.5, 14.5 mm | ||||
| Ø7.8 x 7.0, 8.0, 9.5, 11.0, | ||||
| 12.5, 14.5 mm | ||||
| Ø8.3 x 7.0, 8.0, 9.5, 11.0, | ||||
| 12.5, 14.5 mm | ||||
| Implant-to | ||||
| Abutment | ||||
| Connection | External Hex | Internal Conical | ||
| Connection, | ||||
| Internal Hex | External Hex | Internal Hex | ||
| Material | CP Ti Grade 4 | |||
| (ASTM F67-13) | CP Ti Grade 4 | |||
| (ASTM F67-13) | CP Ti Grade 3 | |||
| (ASTM F67-13) | CP Ti Grade 4 | |||
| (ASTM F67-13) | ||||
| Single Use | Yes | Yes | Yes | Yes |
| Surface | ||||
| Treatment | Sand-blasted, Large grit, | |||
| Acid-etched (SLA) | Sand-blasted, Large grit, | |||
| Acid-etched (SLA) | Sand-blasted (RBM) | Sand-blasted, Large | ||
| grit, Acid-etched (SLA) | ||||
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Shelf Life | 5 years | 5 years | 5 years | 5 years |
| Feature | - Submerged Implant |
- Straight / Tapered
body shape - cutting edge with self-
tapping - 0.8mm thread pitch | - Submerged Implant
- Straight / Tapered
body shape - cutting edge with self-
tapping - 0.8mm thread pitch | - Submerged Implant
- Straight / Tapered
body shape - cutting edge with self-
tapping - 0.5mm & 0.6mm
thread pitch | - Submerged Implant - Straight / Tapered
body shape - cutting edge with self-
tapping - 0.8~1.55mm
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 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. |
| Substantial Equivalence Discussion | | | | |
11
1. Similarities
The subject device has the same characteristic for the followings compared to the predicate device. Indication for use, Design, Material, Single Use, Surface Treatment, Sterilization, Shelf Life, Feature and Principle of Operation.
2. Differences
Diameter & Total Length
The Diameter and Total Length of subject device is slightly different with predicate device but all the subject combination of diameter and length is within the range of the dimension combination of reference device 2. -Connection
The subject device has External Hex connection while the predicate device has Internal Hex connection, but has same connection structure as Megagen's FDA cleared reference device 1.
ന് Discussion
The proposed AnyOne External Fixture and predicate device have common in Indication for use, Design, Material, Single Use, Surface Treatment, Sterilization, Shelf Life, Feature and Principle of Operation. The 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.
12
Cover Screw
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) No. | K203554 | K052369 | K192347 |
| Device Name | |||
| (Compatible | |||
| Implant System) | Cover Screw | ||
| For AnyOne External Implant System | Cover Screw | ||
| For ExFeel Dental Implant System | Cover Screw | ||
| For ST Internal Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | |||
| Use | |||
| Statement | The AnyOne External 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 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 ST Internal Implant System is | ||
| intended to be surgically placed in the | |||
| maxillary or mandibular arches 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 | Image: Design | Image: Design |
| Diameter (Ø) | 3.5, 4.1, 5.0 mm | 3.5, 4.1, 5.0 mm | 3.1, 3.6 mm |
| Total Length | 5.3, 6.2 mm | 6.2 mm | 5.3, 5.9 mm |
| Gingival | |||
| Height | 1.3 mm | 1.3 mm | 0.4 mm |
| Connection | |||
| Interface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection |
| Material | Ti-6A1-4V ELI | ||
| (ASTM F136-13) | CP Ti Grade 3 | ||
| (ASTM F67-13) | Ti-6A1-4V ELI | ||
| (ASTM F136-13) | |||
| Surface | |||
| Treatment | Anodizing, Machined | Anodizing | Anodizing |
| 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 1. | |||
| Indication for use, Design, Diameter, Gingival Height, 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 1.
- -Total Length
The length of subject device is slightly different with reference device 1, but one of length(6.2mm) is same as reference device 1, and the other one(5.3mm) is same as reference device 2.
-Material
The subject device is made of titanium alloy while the reference device 1 is made entirely of commercially pure titanium, but has made with same material with reference device 2. Also, the leveraged materials are being used for similar devices and intended uses.
Discussion ന്
Some of proposed Cover Screw had been FDA cleared with K052639, but it is being submitted to change their identifier with modification of the material only, and to add new models. Therefore, the proposed Cover Screw and reference device 1 have common in Indication for use, Design, Diameter, Gingival Height, Connection Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence.
13
Healing Abutment
| Subject Device | Reference Device 1 | Reference Device 2 | ||
|---|---|---|---|---|
| 510(k) No. | K203554 | K052369 | K053353 | |
| Device Name | ||||
| (Compatible | ||||
| Implant System) | Healing Abutment | |||
| For AnyOne External Implant System | Healing Abutment | |||
| For ExFeel Dental Implant System | Healing Abutment | |||
| For Rescue Dental Implant System | ||||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | |
| Indications for | ||||
| Use | ||||
| Statement | The AnyOne External 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 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 Rescue® 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. These implants are | ||||
| intended to be used where smaller | ||||
| implants have failed. | ||||
| Design | ||||
| Diameter (Ø) | 4.0, 5.0, 6.0, 7.0 mm | 4.0, 5.0, 6.0, 7.0 mm | 6.0, 8.0, 10.0 mm | |
| Total Length | 6.8, 7.7, 7.8, 8.7, 8.8, 9.7, 9.8, | |||
| 10.7, 11.8, 12.7 mm | 7.7, 8.7, 9.7, 10.7, 12.7 mm | 6.3, 7.3, 8.3, 9.3, 10.3, 11.3 mm | ||
| Gingival | ||||
| Height | 2.0, 3.0, 4.0, 5.0, 7.0 mm | 2.0, 3.0, 4.0, 5.0, 7.0 mm | 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 mm | |
| Angulation | Straight | Straight | Straight | |
| Connection | ||||
| Interface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection | |
| Material | Ti-6A1-4V ELI | |||
| (ASTM F136-13) | CP Ti Grade 3 | |||
| (ASTM F67-13) | CP Ti Grade 3 | |||
| (ASTM F67-13) | ||||
| Surface | ||||
| Treatment | Anodizing, Machined | Anodizing, Machined | 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 | ||||
| Subject Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | |
| 510(k) No. | K203554 | K182448 | K150537 | K192436 |
| Device Name | ||||
| (Compatible | ||||
| Implant System) | Esthetic Healing | |||
| Abutment | ||||
| For AnyOne External Implant | ||||
| System | Healing Abutment | |||
| For AnyRidge Octa 1 Implant | ||||
| System | Healing Abutment | |||
| For MiNi Internal Implant | ||||
| System | Healing Abutment | |||
| For Healing Abutments and | ||||
| Cover Screws | ||||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Dentium Co., Ltd. |
| Indications for | ||||
| Use | ||||
| Statement | The AnyOne External | |||
| 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 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. | Dentium Prosthetics are
intended for use as an aid
in prosthetic rehabilitation. |
| Design | Image: Design | Image: Design | Image: Design | Image: Design |
| Diameter (Ø) | 3.5, 4.1, 5.0 mm | 3.2, 4.2, 5.2, 6.2 mm | 3.2, 3.7 mm | 4.8, 6.5 mm |
| Total Length | 6.2, 7.2, 8.2 mm | 8.6, 9.6, 10.6, 11.6,
12.6, 13.6, 14.6, 15.6
mm | 6.3, 6.8, 7.8, 8.8, 9.8
mm | 6.15, 6.30, 7.15, 7.30,
8.15, 8.30, 9.15, 9.30
mm |
| Gingival
Height | 2.5, 3.5, 4.5 mm | 2.5, 3.5, 4.5, 5.5, 6.5,
7.5, 8.5, 9.5 mm | 2.3, 2.8, 3.8, 4.8, 5.8
mm | Not Known |
| Angulation | Straight | Straight | Straight | Straight |
| Connection
Interface | Internal Conical
Connection | Internal Conical
Connection | Internal Conical
Connection | Internal Conical
Connection |
| Material | Ti-6A1-4V ELI
(ASTM F136-13) | Ti-6A1-4V ELI
(ASTM F136-13) | Ti-6A1-4V ELI
(ASTM F136-13) | Ti-6A1-4V ELI
(ASTM F136-13) |
| Surface
Treatment | Anodizing, Machined | Anodizing | Machined | Machined |
| Single Use | Yes | Yes | Yes | Yes |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Principle of
Operation | The Esthetic 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. | The Healing Abutment is
fastened into the female
screw of dental implant and
support the gingival
shaping. |
| Substantial Equivalence Discussion | | | | |
| 1. Similarities
The subject device has the same characteristic for the followings compared to the reference device 1. | | | | |
| | Subject Device | Reference Device 1 | Reference Device 2 | Reference Device 3 |
| 510(k) No. | K203554 | K052369 | K053353 | K150537 |
| Device Name
(Compatible
Implant System) | Temporary Abutment
For AnyOne External
Implant System | Temporary Cylinder
For ExFeel Dental Implant
System | UCLA Temporary
Abutment
For Rescue Dental Implant
System | Temporary Abutment
For MiNi Internal 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 External
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 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 Rescue® 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.
These implants are
intended to be used where
smaller implants have
failed. | 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. |
| Design | | | | |
| Diameter (Ø) | 3.9, 4.5, 4.8, 5.5 mm | 4.8 mm | 5.5, 6.5 mm | 3.0 mm |
| Total Length | 12.0, 12.35 mm | 12.35 mm | 12.0 mm | 13.8, 14.2 mm |
| Post Height | 7.5, 10.0 mm | 7.5 mm | 10.0 mm | 8.5 mm |
| Gingival (Cuff)
Height | 1.3, 2.8 mm | 2.8 mm | 1.3 mm | 2.3 mm |
| Angulation | Straight | Straight | Straight | Straight |
| Connection | External Hex, | External Hex, | External Hex, | Internal Hex, |
| Interface | External Non-Hex | External Non-Hex | External Non-Hex | Internal Non-Hex |
| Material | Ti-6A1-4V ELI
(ASTM F136-13) | CP Ti Grade 3
(ASTM F67-13) | CP Ti Grade 3
(ASTM F67-13) | Ti-6A1-4V ELI
(ASTM F136-13) |
| Surface
Treatment | Machined | Machined | Machined | Machined |
| Single Use | Yes | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Principle of
Operation | The Temporary
Abutment is a
superstructure which is
connected to the
Fixtures or Regular
Abutment using the
Abutment Screw.
It is used to provide
support for provisional
restoration. | The Temporary Cylinder
is a superstructure
which is connected to
the Abutment using the
Screw.
It is used to provide
support for provisional
restoration. | The Temporary
Abutment is a
superstructure which is
connected to the
Fixtures using the Screw.
It is used to provide
support for provisional
restoration. | The Temporary
Abutment is a
superstructure which is
connected to the
Fixtures using the Screw.
It is used to provide
support for provisional
restoration. |
| Substantial Equivalence Discussion | | | | |
| 1. Similarities - The subject device has the same characteristic for the followings compared to the reference device 1.
Indication for use, Design, Angulation, Connection Interface, Surface Treatment, Single Use, Sterilization and
Principle of Operation
- Differences
The subject device has the different characteristic for the followings compared to the reference device 1. | | | | |
1. Similarities
The subject device has the same characteristic for the followings compared to the reference device 1.
Indication for use, Design, Diameter, 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 1.
-
Total Length -
The length of subject device is slightly different with reference device 1, but the half are same as reference device 1, and the other half are lie within combined range of reference device 1 & 2. -
-Material
The subject device is made of titanium alloy while the reference devices are made entirely of commercially pure titanium, the leveraged materials are being used for similar devices and intended uses.
ന് Discussion
Some of proposed Healing Abutment had been FDA cleared with K052639, but it is being submitted to change their identifier with modification of the material only, and to add new models. Therefore, the proposed Healing Abutment and reference device 1 have common in Indication for use, Design, Diameter, Gingival Height, Angulation, Connection Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence.
14
Esthetic Healing Abutment
-Indication for use, Design, Gingival Height, Angulation, Connection Interface, Material, Single Use, Sterilization and Principle of Operation
- Differences
The subject device has the different characteristic for the followings compared to the reference device 1.
Diameter & Total Length -
The dimension of subject device is slightly different with reference device 1 but the dimension of subject device lies within combined range of reference devices.
ന് Discussion
The proposed Esthetic Healing Abutment and reference device 1 have common in Indication for use, Design, Gingival -Height, Angulation, Connection Interface, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence.
15
Temporary Abutment
-
-Diameter
The diameter of subject device is slightly different with reference device 1, but all the diameters of subject device lie within range of reference devices.
Total Length, Post Height, Gingival (Cuff) Height
These dimensions are same as reference device 1 and reference device 2.
16
Material -
The subject device is made of titanium alloy while the reference device 1 is made entirely of commercially pure titanium, but has made with same material with reference device 3. Also, the leveraged materials are being used for similar devices and intended uses.
ന് Discussion -
Some of proposed Temporary Abutment had been FDA cleared with K052639 and K123988 with product name of 'Temporary Cylinder', but it is being submitted to change their identifier with modification of product name and material, and to add new models. Therefore, the proposed Temporary Abutment and reference device 1 have common in Indication for use, Design, Angulation, Connection Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is a straight type and temporarily used.
17
EZ Post Abutment
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) No. | K203554 | K052369 | K192347 |
| Device Name | |||
| (Compatible | |||
| Implant System) | EZ Post Abutment | ||
| For AnyOne External Implant System | Cement Abutment | ||
| For ExFeel Dental Implant System | EZ Post Abutment | ||
| For ST Internal Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | |||
| Use Statement | The AnyOne External 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 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 ST Internal Implant System is | ||
| intended to be surgically placed in | |||
| the maxillary or mandibular arches | |||
| 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) | 4.0, 5.0, 6.0 mm | 4.0, 5.0, 6.0 mm | 4.6, 5.0, 6.0, 7.0 mm |
| Total Length | 9.0, 10.0, 11.0, 12.0 mm | 9.0, 10.0, 11.0, 12.0 mm | 7.5, 8.5, 9.0, 9.1, 9.5, 10.0, 10.1, |
| 10.5, 10.6, 11.0, 11.1, 11.5, 11.6, | |||
| 12.0, 12.1, 12.5, 12.6, 13.0, 13.1, | |||
| 13.5, 13.6, 14.5 mm | |||
| Post Height | 8.0 mm | 8.0 mm | 4.0, 5.5, 7.0 mm |
| Gingival Height | 1.0, 2.0, 3.0, 4.0 mm | 1.0, 2.0, 3.0, 4.0 mm | 1.0, 2.0, 3.0, 4.0, 5.0 mm |
| Angulation | Straight | Straight | Straight |
| Connection | |||
| Interface | External Hex, External Non-Hex | External Hex, External Non-Hex | Internal Hex, Internal Non-Hex |
| Material | Ti-6A1-4V ELI (ASTM F136-13) | CP Ti Grade 3 (ASTM F67-13) | Ti-6A1-4V ELI (ASTM F136-13) |
| Surface | |||
| Treatment | Anodizing | Anodizing | Anodizing |
| 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 Abutment | |||
| Screw. It replaces the functions of | |||
| the missing teeth as a dental | |||
| abutment. | The Cement 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 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. | |||
| Substantial Equivalence Discussion | |||
| Similarities | |||
| Subject Device | Reference Device 1 | Reference Device 2 | |
| 510(k) No. | K203554 | K110955 | K052369 |
| Device Name | |||
| (Compatible | |||
| Implant System) | Angled Abutment | ||
| For AnyOne External Implant System | Angled Abutment | ||
| For AnyRidge Internal Implant | |||
| System | Cement 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 External 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 AnyRidge 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 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) | 4.0, 5.0, 6.0 mm | 4.0, 5.0, 6.0, 7.0 mm | 4.0, 5.0, 6.0 mm |
| Total Length | 9.0, 11.0 mm | 11.4, 12.4, 13.4, 14.4 mm | 9.0, 10.0, 11.0, 12.0 mm |
| Post Height | 7.0 mm | 7.0 mm | 8.0 mm |
| Gingival Height | 2.0, 4.0 mm | 1.8, 2.8, 3.8, 4.8 mm | 1.0, 2.0, 3.0, 4.0 mm |
| Angulation | 15°, 25° | 15°, 25° | Straight |
| Connection | External Hex, | Internal Hex, | External Hex, |
| Interface | External Non-Hex | Internal Non-Hex | External Non-Hex |
| Material | Ti-6A1-4V ELI (ASTM F136-13) | Ti-6A1-4V 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 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 Cement 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. | |||
| Substantial Equivalence Discussion | |||
| 1. Similarities | |||
| The subject device has the same characteristic for the followings compared to the reference device 1. | |||
| Indication for use, Design, Diameter, Post Height, Angulation, 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 device 1.
Total Length, Gingival Height
- The Total Length of subject device is slightly shorter than reference device 1, but it is due to the connection difference,
and all the Lengths of subject device lie within range of reference device 2.
The Gingival Height of subject device is slightly different with reference device 1, but all the Gingival Heights of subject
device lie within combined range of reference devices.
Also, 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.
Connection Interface
The subject device has External Hex connection while the reference device 1 has Internal Hex connection, but has
same connection structure as reference device 2. Also, the multiple predicate & reference devices for External Hex
connection are presented in the other component comparison charts. | | | |
The subject device has the same characteristic for the followings compared to the reference device 1.
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 1.
- Material -
- The subject device is made of titanium alloy while the reference device 1 is made entirely of commercially pure titanium, but has made with same material with reference device 2. Also, the leveraged materials are being used for similar devices and intended uses.
ന് Discussion
- The proposed EZ Post Abutment had been FDA cleared under K052639 with product name of 'Cement Abutment', but it is being submitted to change their identifier with modification of product name and material. Therefore, the proposed EZ Post Abutment and reference device 1 have common in Indication for use, Design, Angulation, Connection Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation. The material difference is explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is straight type.
18
Angled Abutment
19
Discussion ന്
The proposed Angled Abutment is being submitted to add in Megagen's existing prosthetic portfolio which had been FDA cleared as with reference device 1. Therefore, the proposed Angled Abutment and reference device 1 have common in Indication for use, Design, Diameter, Post Height, Angulation, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence, but the fatigue test was performed on the subject device 1 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 reference device 1 and the differences are not affecting the substantial equivalence.
20
Milling Abutment
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) No. | K203554 | K081302 | K192347 |
| Device Name | |||
| (Compatible | |||
| Implant System) | Milling Abutment | ||
| For AnyOne External Implant System | Milling Abutment | ||
| For Rescue External Implant System | Milling Abutment | ||
| For ST Internal Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | |||
| Use Statement | The AnyOne External 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 Rescue External 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. These | |||
| implants are intended to be used | |||
| where smaller implants have failed. | The ST Internal Implant System is | ||
| intended to be surgically placed in the | |||
| maxillary or mandibular arches 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 subject device | Image: Design of reference device 1 | Image: Design of reference device 2 |
| Diameter (Ø) | 4.0, 5.0, 6.0, 7.0 mm | 6.0, 7.0 mm | 4.0, 5.0, 6.0, 7.0 mm |
| Total Length | 10.0, 11.0, 12.0, 13.0 mm | 10.0, 11.0, 12.0, 13.0 mm | 12.0, 14.5, 14.6 mm |
| Post Height | 9.0 mm | 9.0 mm | 9.0, 10.5mm |
| Gingival Height | 1.0, 2.0, 3.0, 4.0 mm | 1.0, 2.0, 3.0, 4.0 mm | 1.5, 3.0 mm |
| Angulation | Straight | Straight | Straight |
| Connection | |||
| Interface | External Hex, External Non-Hex | External Hex, External Non-Hex | Internal Hex |
| Material | Ti-6A1-4V ELI (ASTM F136-13) | CP Ti Grade 4 (ASTM F67-13) | Ti-6A1-4V ELI (ASTM F136-13) |
| Surface | |||
| Treatment | Anodizing | Anodizing | Anodizing |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle of | |||
| Operation | The Milling 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 Milling 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 Milling 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. | |||
| Substantial Equivalence Discussion | |||
| 1. Similarities | |||
| The subject device has the same characteristic for the followings compared to the reference device 1. | |||
| Indication for use, Design, Total Length, Post Height, 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 1. | |||
| Diameter |
- The diameter of subject device is slightly different with reference device 1, but all the diameters of subject device lie | | | |
| within combined range of reference devices. - Material
The subject device is made of titanium alloy while the reference device 1 is made entirely of commercially pure
titanium, but has made with same material with reference device 2. Also, the multiple predicate & reference devices
for titanium alloy are presented in the other component comparison charts. | | | |
| 3. Discussion
The proposed Milling Abutment is being submitted to add in Megagen's existing prosthetic portfolio which had been - FDA cleared. Therefore, the proposed Milling Abutment and reference device 1 have common in Indication for use,
Design, Total Length, Post Height, Gingival Height, Angulation, Connection Interface, Surface Treatment, Single Use,
Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence. | | | |
21
Gold Abutment
| Subject Device | Reference Device | |
|---|---|---|
| 510(k) No. | K203554 | K052369 |
| Device Name | ||
| (Compatible | ||
| Implant System) | Gold Abutment | |
| For AnyOne External Implant System | UCLA Gold Abutment | |
| For ExFeel Dental Implant System | ||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | ||
| Use Statement | The AnyOne External 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 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 | Image: Design |
| Diameter (Ø) | 4.0, 4.5, 5.5 mm | 4.0, 4.5, 5.5 mm |
| Total Length | 11.0, 11.2 mm | 11.0, 11.2 mm |
| Post Height | 10.0 mm | 10.0 mm |
| Gingival Height | 1.0, 1.2 mm | 1.0, 1.2 mm |
| Angulation | Straight | Straight |
| Connection | External Hex, | External Hex, |
| Interface | External Non-Hex | External Non-Hex |
| 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 Abutment is connected to the fixture | |
| using the Abutment Screw and used for fabrication | ||
| of abutment for either screw or cement retained | ||
| restorations by casting gold alloy. | The UCLA Gold Abutment is connected to the | |
| fixture and used for fabrication of abutment for | ||
| either screw or cement retained restorations by | ||
| casting gold alloy. | ||
| 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, Material, l Surface Treatment, Single Use, Sterilization and Principle of Operation.
2. Differences
N/A -
-
- Discussion
-The proposed Gold Abutment had been FDA cleared under K052639 with product name of 'UCLA Gold Abutment', but it is being submitted to change their identifier with modification of product name only. Therefore, the proposed Gold Abutment 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 straight type.
- Discussion
22
Abutment Screw
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) No. | K203554 | K052369 | K052369 |
| Device Name | |||
| (Compatible | |||
| Implant System) | Abutment Screw | ||
| For AnyOne External Implant System | Coping Screw | ||
| For ExFeel Dental Implant System | Temporary (Cylinder) 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 External 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 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 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: Abutment Screw Design | Image: Coping Screw Design | Image: Temporary (Cylinder) Screw Design |
| Diameter (Ø) | 2.45, 2.5 mm | 2.5 mm | 2.45 mm |
| Total Length | 4.8, 7.5 mm | 7.5 mm | 4.8 mm |
| Connection | |||
| Interface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection |
| Material | Ti-6A1-4V ELI | ||
| (ASTM F136-13) | Ti-6A1-4V ELI | ||
| (ASTM F136-13) | Ti-6A1-4V ELI | ||
| (ASTM F136-13) | |||
| Surface | |||
| Treatment | Machined | Machined | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle of | |||
| Operation | The Abutment Screw is used for | ||
| connecting Fixture to Abutment | |||
| or Abutment to Cylinder. | The Coping Screw is used for | ||
| connecting Fixture to Abutment. | The Temporary (Cylinder) Screw | ||
| is used for connecting Abutment | |||
| to Cylinder. | |||
| Substantial Equivalence Discussion | |||
| Subject Device | Reference Device | ||
| 510(k) No. | K203554 | K052369 | |
| Device Name | |||
| (Compatible | |||
| Implant System) | Regular Abutment | ||
| For AnyOne External Implant System | Regular Abutment | ||
| For ExFeel Dental Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | |
| Indications for | |||
| Use Statement | The AnyOne External 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 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 Design | Image: Reference Device Design | |
| Diameter (Ø) | 4.5, 4.8 mm | 4.5, 4.8 mm | |
| Total Length | 3.0, 3.8, 4.0, 4.8, 5.5, 5.8, 7.0, 8.5 mm | 3.0, 3.8, 4.0, 4.8, 5.5, 5.8, 7.0, 8.5 mm | |
| Post Height | 1.8 mm | 1.8 mm | |
| Gingival Height | 1.2, 2.0, 3.0, 4.0 mm | 1.2, 2.0, 3.0, 4.0 mm | |
| Angulation | Straight | Straight | |
| Connection | |||
| Interface | External Hex, | ||
| External Non-Hex | External Hex, | ||
| External Non-Hex | |||
| Material | Ti-6A1-4V ELI | ||
| (ASTM F136-13) | CP Ti Grade 3 | ||
| (ASTM F67-13) | |||
| Surface | |||
| Treatment | Machined | Machined | |
| Single Use | Yes | Yes | |
| Sterilization | Non-sterile | Non-sterile | |
| Principle of | |||
| Operation | The Regular Abutment is a pre-manufactured | ||
| prosthetic component connected to the | |||
| endosseous dental implant using the Regular | |||
| Abutment Screw for aid in prosthetic | |||
| rehabilitation. | The Regular Abutment is a pre-manufactured prosthetic | ||
| component connected to the endosseous dental | |||
| implant using the Regular Abutment Screw 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, Gingival Height, Angulation, Connection Interface,
Surface Treatment, Single Use, Sterilization and Principle of Operation. | | | |
| 2. Differences - Material
The subject device is made of titanium alloy while the reference device is made entirely of commercially pure
titanium, the leveraged materials are being used for similar devices and intended uses. | | | |
| 3. Discussion | | | |
| | Subject Device | Reference Device | |
| 510(k) No. | K203554 | K052369 | |
| Device Name
(Compatible
Implant System) | Regular Abutment Screw
For AnyOne External Implant System | Regular Abutment Screw
For ExFeel Dental Implant System | |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | |
| Indications for
Use Statement | The AnyOne External 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 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) | 2.95, 3.5 mm | 2.95, 3.5 mm | |
| Total Length | 7.9, 8.85, 9.05, 9.85, 10.55, 10.85, 11.85, 12.05,
13.55 mm | 7.9, 8.85, 9.05, 9.85, 10.55, 10.85, 11.85, 12.05,
13.55 mm | |
| Connection
Interface | Internal Conical Connection | Internal Conical Connection | |
| Material | Ti-6A1-4V ELI
(ASTM F136-13) | CP Ti Grade 3
(ASTM F67-13) | |
| Surface
Treatment | Machined | Machined | |
| Single Use | Yes | Yes | |
| Sterilization | Non-sterile | Non-sterile | |
| Principle of
Operation | The Regular Abutment Screw is used for connecting
Fixture to Regular Abutment. | The Regular Abutment Screw is used for connecting
Fixture to Regular Abutment. | |
| 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, Total Length, Connection Interface, Material, Surface Treatment, Single Use, -Sterilization and Principle of Operation.
Differences 2.
- N/A -
3. Discussion
- The proposed Abutment Screw had been FDA cleared under K052639 with product name of 'Coping Screw' and י 'Temporary (Cylinder) Screw', but it is being submitted to change their identifier with modification of product name only. Therefore, the proposed Abutment Screw and reference devices have common in all the items in the comparison chart.
23
Regular Abutment
The proposed Regular Abutment had been FDA cleared with K052639, but it is being submitted to change their identifier with modification of material only. Therefore, the proposed Regular Abutment and reference device have common in all the items except the material difference is explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is straight type.
24
Regular Abutment Screw
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, Surface Treatment, Single Use, Sterilization and Principle of Operation.
Differences 2.
- Material -
The subject device is made of titanium alloy while the reference device is made entirely of commercially pure titanium, the leveraged materials are being used for similar devices and intended uses.
ന് Discussion
The proposed Regular Abutment Screw had been FDA cleared with K052639, but it is being submitted to change their identifier with modification of material only. Therefore, the proposed Regular Abutment Screw and reference device have common in all the items except the material difference is explained not affecting on the substantial equivalence.
25
Multi-unit Abutment
| Subject Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | |
|---|---|---|---|---|
| 510(k) No. | K203554 | K052369 | K160670 | K123988 |
| Device Name | ||||
| (Compatible | ||||
| Implant System) | Multi-unit Abutment | |||
| For AnyOne External | ||||
| Implant System | Regular Abutment | |||
| For ExFeel Dental Implant | ||||
| System | Esthetic-low Abutment | |||
| For ET US SS Prosthetic | ||||
| System | Multi-unit Abutment | |||
| For AnyOne 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 External | |||
| 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 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. | 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. | 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) | 4.8 mm | 4.5, 4.8 mm | 4.8, 5.5 mm | 5.0 mm |
| Total Length | 2.0, 3.0, 4.0, 5.0, 6.0 | |||
| mm | 3.0, 3.8, 4.0, 4.8, 5.5, | |||
| 5.8, 7.0, 8.5 mm | 2.1, 2.2, 3.0, 3.1, 4.0, | |||
| 4.1, 5.0, 5.1 mm | 6.2, 7.2, 8.2, 9.2, 10.2 | |||
| mm | ||||
| Post Height | 1.0 mm | 1.8 mm | Not Known | 1.8 mm |
| Gingival Height | 1.0, 2.0, 3.0, 4.0, 5.0 | |||
| mm | 1.2, 2.0, 3.0, 4.0 mm | Not Known | 1.5, 2.5, 3.5, 4.5, 5.5 | |
| mm | ||||
| Angulation | Straight | Straight | Straight | Straight |
| Connection | ||||
| Interface | External Non-Hex | External Hex, | ||
| External Non-Hex | External Hex | Internal Hex, | ||
| Internal Non-Hex | ||||
| Material | Ti-6A1-4V ELI | |||
| (ASTM F136-13) | CP Ti Grade 3 | |||
| (ASTM F67-13) | Titanium | |||
| (ASTM F67) | Ti-6A1-4V ELI | |||
| (ASTM F136-13) | ||||
| Surface | ||||
| Treatment | Anodizing | Machined | Not Known | Anodizing |
| Single Use | Yes | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Principle of | ||||
| Operation | The Multi-unit | |||
| Abutment is a pre- | ||||
| manufactured | ||||
| prosthetic component | ||||
| connected to the | ||||
| endosseous dental | ||||
| implant using the Multi- | ||||
| unit Abutment Screw for | ||||
| aid in prosthetic | ||||
| rehabilitation. | The Regular Abutment is | |||
| a pre-manufactured | ||||
| prosthetic component | ||||
| connected to the | ||||
| endosseous dental | ||||
| implant using the | ||||
| Regular Abutment | ||||
| Screw for aid in | ||||
| prosthetic rehabilitation. | The Esthetic-low | |||
| Abutment is a pre- | ||||
| manufactured | ||||
| prosthetic component | ||||
| connected to the | ||||
| endosseous dental | ||||
| implant using the | ||||
| Esthetic-low Abutment | ||||
| Screw for aid in | ||||
| prosthetic rehabilitation. | The Multi-unit | |||
| Abutment is a pre- | ||||
| manufactured | ||||
| prosthetic component | ||||
| connected to the | ||||
| endosseous dental | ||||
| implant using the Multi- | ||||
| unit Abutment Screw for | ||||
| aid in prosthetic | ||||
| rehabilitation. | ||||
| Substantial Equivalence Discussion |
- Similarities
The subject device has the same characteristic for the followings compared to the reference device 1.
Indication for use, Design, Diameter, Angulation Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation.
- Differences
The subject device has the different characteristic for the followings compared to the reference device 1.
26
Total Length, Post Height, Gingival Height
Almost all the lengths of subject device lie within combined range of reference device 1 & 2. The only difference is that slight shorter length(2.0mm) is added in the subject device but it is a very slight difference(0.1mm) between the shortest length(2.1mm) of reference device2.
The Post Height and Gingival Height are slightly different with reference devices, but 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.
Material -
The subject device is made of titanium alloy while the reference device 1 is made entirely of commercially pure titanium, but has made with same material with reference device 3. Also, the leveraged materials are being used for similar devices and intended uses.
Discussion 3.
The proposed Multi-unit Abutment is being submitted to add in Megagen's existing prosthetic portfolio which had been FDA cleared as with refence device 3. It has a different connection interface, but the reference device 1 and reference device 2 have same structure and characteristics with subject device. The proposed Multi-unit Abutment and reference device 1 have common in Indication for use, Design, Diameter, Angulation, Connection Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since is straight type.
27
Multi-unit Angled Abutment
| Subject Device | Reference Device 1 | Reference Device 2 | ||
|---|---|---|---|---|
| 510(k) No. | K203554 | K182448 | K052369 | |
| Device Name | ||||
| (Compatible | ||||
| Implant System) | Multi-unit Angled Abutment | |||
| For AnyOne External Implant System | Multi-unit Angled Abutment | |||
| For AnyRidge Octa 1 Implant System | Regular 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 External 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 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) | 4.8 mm | 4.8 mm | 4.5, 4.8 mm | |
| Total Length | 3.65, 4.65, 5.13, 5.65, 6.13 mm | 6.8, 7.48, 7.8, 8.48, 8.5, 8.8, 8.98, | ||
| 9.5, 9.98, 10.5 mm | 3.0, 3.8, 4.0, 4.8, 5.5, 5.8, 7.0, 8.5 | |||
| mm | ||||
| Post Height | 2.2 mm | 2.2 mm | 1.8 mm | |
| Gingival Height | 2.0, 3.0, 4.0, 5.0 mm | 2.3, 3.3, 4.3mm | 1.2, 2.0, 3.0, 4.0 mm | |
| Angulation | 17°, 30° | 17°, 30° | Straight | |
| Connection | ||||
| Interface | External Hex, External Non-Hex | Internal Octa, Internal Non-Octa | External Hex, External Non-Hex | |
| Material | Ti-6A1-4V ELI (ASTM F136-13) | Ti-6A1-4V 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 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. | 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. | The Regular Abutment is a pre- | |||
| manufactured prosthetic component | ||||
| connected to the endosseous dental | ||||
| implant using the Regular Abutment | ||||
| Screw 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 1. | ||||
| Indication for use, Design, Diameter, Post Height, Angulation, 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 device 1.
Total Length, Gingival Height
The Total Length of subject device is slightly shorter than reference device 1, but it is due to the connection difference
and all the lengths lie within range of reference device 2. The Gingival Height of subject device is slightly different
with reference device 1,, 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. | | | | |
| | Subject Device | Reference Device 1 | Reference Device 2 | |
| 510(k) No. | K203554 | K123988 | K182448 | |
| Device Name
(Compatible
Implant System) | Multi-unit Abutment Screw
For AnyOne External Implant System | Multi-unit Abutment Screw
For AnyOne Internal Implant System | Multi-unit Abutment Screw
For AnyRidge Octa 1 Implant System | |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | |
| Indications for
Use Statement | The AnyOne External 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. | 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 | Image: Design of subject device | Image: Design of reference device 1 | Image: Design of reference device 2 | |
| Diameter (Ø) | 2.4, 2.9 mm | 2.95 mm | 2.1 mm | |
| Total Length | 6.7, 6.8, 7.7, 8.7, 9.7, 10.7 mm | 11.5, 12.5, 13.5, 14.5, 15.5 mm | 7.0 mm | |
| Connection
Interface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection | |
| Material | Ti-6A1-4V ELI
(ASTM F136-13) | Ti-6A1-4V ELI
(ASTM F136-13) | Ti-6A1-4V ELI
(ASTM F136-13) | |
| Surface
Treatment | Anodizing, Machined | Machined | Machined | |
| Single Use | Yes | Yes | Yes | |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | |
| Principle of
Operation | The Multi-unit Abutment Screw is
used for connecting Multi-unit
Abutment or Multi-unit Angled
Abutment to the fixture. | The Multi-unit Abutment Screw is
used for connecting Multi-unit
Abutment to the fixture. | The Multi-unit Abutment Screw is
used for connecting Multi-unit
Abutment or Multi-unit Angled
Abutment to the fixture. | |
| Substantial Equivalence Discussion | | | | |
| Healing Cap | | | | |
| | Subject Device | Reference Device 1 | Reference Device 2 | Reference Device 3 |
| 510(k) No. | K203554 | K052369 | K123988 | K171142 |
| Device Name
(Compatible
Implant System) | Healing Cap
For AnyOne External Implant
System | Healing Cap
For ExFeel Dental Implant
System | Octa Healing Cap
For AnyOne Internal
Implant System | Healing Cap Multi-Unit
Titanium |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Nobel Biocare USA LLC |
| Indications for
Use
Statement | The AnyOne External
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 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. | The Healing Cap Multi-unit
Titanium is a
premanufactured
prosthetic component to be
directly connected to the
dental abutment during
soft tissue healing to
protect the internal
connection of the
abutments and prepare the
soft tissue for the
prosthetic procedure.
Maximum intra-oral use is
180-days. |
| Design | | | | |
| Diameter (Ø) | 4.9, 5.0, 6.8 mm | 4.8, 5.0 mm | 4.0, 5.0, 5.2, 6.0 mm | 5.0, 6.0, 6.9 mm |
| Total Length | 4.2, 6.1 mm | 4.4, 6.1 mm | 3.65, 3.7, 3.75, 6.1 mm | 4.1, 5.5 mm |
| Connection
Interface | One-piece
(with integrated screw)
Two-piece
(with titanium alloy screw) | One-piece
(with integrated screw) | One-piece
(with integrated screw)
Two-piece
(with titanium alloy
screw) | One-piece Healing Cap
(with integrated screw) |
| Material | Ti-6A1-4V ELI
(ASTM F136-13) | CP Ti Grade 3
(ASTM F67-13) | Ti-6A1-4V ELI
(ASTM F136-13) | Ti-6A1-4V ELI
(ASTM F136-13) |
| Surface
Treatment | Machined | Machined | Machined | Not Known |
| Single Use | Yes | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Sterile (Gamma) |
| Principle of
Operation | The Healing Cap is used for
protecting Regular
Abutment or Multi-unit
(Angled) Abutment and
minimizing irritation to
tongue and oral mucosa
during period of gingival
healing. It is connected to
the Abutment using its
threaded part or Cylinder
Screw | The Healing Cap is used for
protecting Abutment and
minimizing irritation to
tongue and oral mucosa
during period of gingival
healing. It is connected to
the Abutment using its
threaded part. | The Octa Healing Cap is
used for protecting
Abutment and minimizing
irritation to tongue and oral
mucosa during period of
gingival healing. It is
connected to the Abutment
using its threaded part or
Cylinder Screw | The Healing Cap Multi-unit
Titanium is used for
protecting Multi-unit
Abutment and minimizing
irritation to tongue and oral
mucosa during period of
gingival healing. It is
connected to the Abutment
using its threaded part. |
| Substantial Equivalence Discussion | | | | |
| 1. Similarities | | | | |
| The subject device has the same characteristic for the followings compared to the reference device 1. | | | | |
| Indication for use, Design, 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 1. | | | | |
| Diameter, Total Length | | | | |
| The Diameter and Total Length of subject device is slightly different with reference device 1, but all the dimensions | | | | |
| lie within combined range of reference devices. | | | | |
| Connection Interface | | | | |
| The subject device has one-piece and two-piece types both while the reference device 1 has one-piece type only, but | | | | |
| the reference device 2 has same connection interface as subject device. | | | | |
| Material | | | | |
| The subject device is made of titanium alloy while the reference device 1 is made entirely of commercially pure | | | | |
| titanium, but has made with same material with reference device 2 & 3. Also, the leveraged materials are being used | | | | |
| for similar devices and intended uses. | | | | |
-Connection Interface
The subject device has External Hex connection while the reference device 1 has Internal Hex connection, but has same connection structure as reference device 2. Also, the leveraged materials are being used for similar devices and intended uses.
ന് Discussion
The proposed Multi-unit Angled Abutment is being submitted to add in Megagen's existing prosthetic portfolio which had been FDA cleared as with reference device 1. It has a different connection interface, but the reference device 2 has same structure, intended use and characteristics with subject device. The differences are explained not affecting on the substantial equivalence, but the fatigue test was performed on the subject device 1 to confirm the substantial equivalence 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 reference device 1 and the differences are not affecting the substantial equivalence.
28
Multi-unit Abutment Screw
1. Similarities
The subject device has the same characteristic for the followings compared to the reference device 1.
Indication for use, Design, Connection Interface, Material, Single Use, Sterilization and Principle of Operation Differences
2.
The subject device has the different characteristic for the followings compared to the reference device 1.
- Diameter -
The Diameter of subject device is slightly different with reference device 1, but and all the diameter lie within combined range of reference devices.
Discussion ന്
The proposed Multi-unit Abutment Screw is being submitted to add in Megagen's existing prosthetic portfolio which י had been FDA cleared. Therefore, the proposed Multi-unit Abutment Screw and reference device 1 have common in Indication for use, Design, Connection Interface, Material, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence.
29
30
ന് Discussion
- asses
One of proposed Healing Cap had been FDA cleared with K052639 and K123988, but it is being submitted to change -Healing Cap and reference device 1 have common Indication for use, Design, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence.
31
| Temporary Cylinder | Subject Device | Reference Device 1 | Reference Device 2 | Reference Device 3 |
|---|---|---|---|---|
| 510(k) No. | K203554 | K123988 | K182091 | K182448 |
| Device Name | Temporary Cylinder | |||
| For AnyOne External | ||||
| Implant System | Temporary Cylinder | |||
| For AnyOne Internal | ||||
| Implant System | Esthetic-low Temporary | |||
| Cylinder | ||||
| For Osstem Abutment | ||||
| System | Temporary Abutment | |||
| For AnyRidge Octa 1 | ||||
| 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 External | |||
| 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. | Osstem Abutment System | |||
| is intended for use with a | ||||
| dental implant to provide | ||||
| support for | ||||
| prosthetic | ||||
| restorations | ||||
| such as crowns, bridges, or | ||||
| overdentures. | 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) | 4.8 mm | 3.87, 4.8, 5.8 mm | 4.8, 5.5 mm | 4.0, 4.5, 5.0 mm |
| Total Length | 12.0 mm | 10.0 mm | 12 mm | 14.85, 15.85, 16.35, |
| 17.35 mm | ||||
| Post Height | 8.5 mm | 7.0 mm | Not Known | 10 mm |
| Gingival (Cuff) | ||||
| Height | 3.0 mm | 3.0 mm | Not Known | 2.0, 3.0 mm |
| Angulation | Straight | Straight | Straight | Straight |
| Connection | ||||
| Interface | Non-Hex | Octa, Non-Octa | Hex | Internal Octa, Internal |
| Non-Octa | ||||
| Material | Ti-6A1-4V ELI | |||
| (ASTM F136-13) | CP Ti Grade 4 | |||
| (ASTM F67-13) | Titanium Gr. 3 | |||
| (ASTM F67) | Ti-6A1-4V ELI | |||
| (ASTM F136-13) | ||||
| Surface | ||||
| Treatment | Machined | Machined | Not Known | Machined |
| Single Use | Yes | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Principle of | ||||
| Operation | The Temporary Cylinder is | |||
| used in conjunction with | ||||
| Multi-unit Abutment or | ||||
| Multi-unit Angled | ||||
| Abutment to provide | ||||
| support for provisional | ||||
| restoration. It is connected | ||||
| to the Abutment using | ||||
| Cylinder Screw | The Temporary Cylinder is | |||
| used in conjunction with | ||||
| Abutment to provide | ||||
| support for provisional | ||||
| restoration. It is connected | ||||
| to the Abutment using | ||||
| Cylinder Screw | The Esthetic-low | |||
| Temporary Cylinder is used | ||||
| in conjunction with Multi | ||||
| Abutment, US Multi Angled | ||||
| Abutment or Esthetic-low | ||||
| Abutment to provide | ||||
| support for provisional | ||||
| restoration. It is connected | ||||
| to the Abutment using | ||||
| Cylinder Screw | The Temporary Abutment is | |||
| used in conjunction with | ||||
| Fixture to provide support | ||||
| for provisional restoration. | ||||
| It is connected to Fixture | ||||
| using the Screw. |
-
Total Length, Post Height -
The Total Length and Post Height of subject device is slightly different with reference device 1 but all the dimensions of subject device lie within combined range of reference devices. -
-Connection Interface
The Connection Interface of subject device is different with reference device 1, but Non-Hex in the subject device and Non-Octa in predicate device are same structure without anti-rotation function which can be connected in any direction.
32
Material -
The subject device is made of titanium alloy while the reference device 1 is made entirely of commercially pure titanium, but has made with same material with reference device 3. Also, the leveraged materials are being used for similar devices and intended uses.
ന് Discussion
The proposed Temporary Cylinder is being submitted to add in Megagen's existing prosthetic portfolio which had been FDA cleared. Therefore, the proposed Temporary Cylinder and reference device 1 have common in Indication for use, Design, Diameter, Angulation, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is straight type and temporarily used.
33
EZ Post Cylinder
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) No. | K203554 | K052369 | K192347 |
| Device Name | |||
| (Compatible Implant | |||
| System) | EZ Post Cylinder | ||
| For AnyOne External Implant | |||
| System | Conical Abutment | ||
| For ExFeel Dental Implant System | EZ Post Abutment | ||
| For ST Internal Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for Use | |||
| Statement | The AnyOne External 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 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 ST Internal Implant System is | ||
| intended to be surgically placed in | |||
| the maxillary or mandibular arches | |||
| 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: [EZ Post Cylinder design] | Image: [Conical Abutment design] | Image: [EZ Post Abutment design] |
| Diameter (Ø) | 5.0 mm | 5.0 mm | 4.6, 5.0, 6.0, 7.0 mm |
| Total Length | 8.5 mm | 8.5 mm | 7.5 - 14.5 mm |
| Post Height | 7.7 mm | 7.7 mm | 4.0, 5.5, 7.0 mm |
| Gingival (Cuff) | |||
| Height | 0.8 mm | 0.8 mm | 1.0, 2.0, 3.0, 4.0, 5.0mm |
| Angulation | Straight | Straight | Straight |
| Connection | |||
| Interface | Hex, Non-Hex | Hex, Non-Hex | Internal Hex, |
| Internal Non-Hex | |||
| Material | Ti-6A1-4V ELI | ||
| (ASTM F136-13) | CP Ti Grade 3 | ||
| (ASTM F67-13) | Ti-6A1-4V ELI | ||
| (ASTM F136-13) | |||
| Surface Treatment | Machined | Machined | 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 Regular | |||
| Abutment to provide support | |||
| for cement and screw type final | |||
| prosthesis. It is connected to the | |||
| Abutment using Abutment | |||
| Screw. | The Conical Abutment is used in | ||
| conjunction with Regular | |||
| 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. | |||
| Substantial Equivalence Discussion |
Similarities 1.
The subject device has the same characteristic for the followings compared to the reference device 1.
Indication for use, Design, Diameter, Total Length, Post Height, Gingival (cuff) Height, Angulation, Connection -Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation.
Differences 2.
Material -
The subject device is made of titanium alloy while the reference device 1 is made entirely of commercially pure titanium, but has made with same material with reference device 2. Also, the leveraged materials are being used for similar devices and intended uses.
Discussion ന്
The proposed EZ Post Cylinder had been FDA cleared under K052639 with product name of 'Conical Abutment', but it is being submitted to change their with modification of product name and material. Therefore, the proposed EZ Post Cylinder and reference device 1 have common in Indication for use, Design, Diameter, Total Length, Angulation, Connection Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation. The material difference is explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is straight type.
34
Gold Cylinder
| Subject Device | Reference Device | CCM Cylinder | Subject Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | |
|---|---|---|---|---|---|---|---|
| 510(k) No. | K203554 | K123988 | 510(k) No. | K203554 | K123988 | K182448 | K123988 |
| Device Name | |||||||
| (Compatible | |||||||
| Implant System) | Gold Cylinder | ||||||
| For AnyOne External Implant System | Gold Cylinder | ||||||
| For AnyOne Internal Implant System | Device Name | CCM Cylinder | |||||
| For AnyOne External | |||||||
| Implant System | CCM Cylinder | ||||||
| For AnyOne Internal | |||||||
| Implant System | CCM Abutment | ||||||
| For AnyRidge Octa 1 | |||||||
| Implant System | Gold Cylinder | ||||||
| For AnyOne Internal | |||||||
| Implant System | |||||||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Manufacturer | MegaGen Implant Co., | |||
| Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | ||||
| Indications for | |||||||
| Use Statement | The AnyOne External 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 External | ||||||
| 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. | 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: red cylinder | Image: red cylinder | Design | ||||
| Diameter (Ø) | 4.8 mm | 4.0, 4.8, 5.1, 6.0 mm | Diameter (Ø) | 4.8 mm | 4.0, 5.1, 6.0 mm | 3.8 mm | 4.0, 4.8, 5.1, 6.0 mm |
| Total Length | 13.0 mm | 12.0, 13.0 mm | Total Length | 13.0, 15.0 mm | 12.0 mm | 14.65, 16.15 mm | 12.0, 13.0 mm |
| Post Height | 10.0 mm | 10.0 mm | Post Height | 10.0, 13.0 mm | 10.0 mm | 11.6 mm | 10.0 mm |
| Gingival (Cuff) | |||||||
| Heights | 3.0 mm | 2.0, 3.0 mm | Gingival (Cuff) | ||||
| Heights | 2.0, 3.0 mm | 2.0 mm | 1.0 mm | 2.0, 3.0 mm | |||
| Angulation | Straight | Straight | Angulation | Straight | Straight | Straight | Straight |
| Connection | Hex, Non-Hex | Octa, Non-Octa | Connection | ||||
| Interface | Hex, Non-Hex | Octa, Non-Octa | Octa, Non-Octa | Octa, Non-Octa | |||
| Hex, Non-Hex | |||||||
| Interface | Hex, Non-Hex | Hex, Non-Hex | Material | Body: Co-Cr-Mo Alloy | |||
| Sleeve: POM | Body: Co-Cr-Mo Alloy | ||||||
| Sleeve: POM | Body: Co-Cr-Mo Alloy | ||||||
| Sleeve: POM | Body: Gold Alloy | ||||||
| Sleeve: POM | |||||||
| Material | Body: Gold Alloy | ||||||
| Sleeve: POM | Body: Gold Alloy | ||||||
| Sleeve: POM | Surface | ||||||
| Treatment | N/A | N/A | N/A | N/A | |||
| Surface | |||||||
| Treatment | N/A | N/A | Single Use | Yes | Yes | Yes | Yes |
| Single Use | Yes | Yes | Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Sterilization | Non-sterile | Non-sterile | Principle of | ||||
| Operation | The CCM Cylinder is used in | ||||||
| conjunction with Regular | |||||||
| Abutment or Multi-unit | |||||||
| (Angled) Abutment to | |||||||
| provide support for screw | |||||||
| type final prosthesis by | |||||||
| casting with non-precious | |||||||
| metal alloy (CCM alloy). It is | |||||||
| connected to the Abutment | |||||||
| using Abutment Screw or | |||||||
| Cylinder Screw. | The CCM Cylinder is used in | ||||||
| conjunction with Abutment | |||||||
| to provide support for | |||||||
| screw type final prosthesis | |||||||
| by casting with non- | |||||||
| precious metal alloy (CCM | |||||||
| alloy). It is connected to the | |||||||
| Abutment using the Screw. | The CCM Abutment is used | ||||||
| in conjunction with Fixture | |||||||
| to provide support for | |||||||
| screw type final prosthesis | |||||||
| by casting with non- | |||||||
| precious metal alloy (CCM | |||||||
| alloy). It is connected to the | |||||||
| Fixture using the Screw. | The Gold Cylinder is used in | ||||||
| conjunction with Abutment | |||||||
| to provide support for | |||||||
| screw type final prosthesis | |||||||
| by casting with gold alloy. It | |||||||
| is connected to the | |||||||
| Abutment using the Screw. | |||||||
| Principle of | |||||||
| Operation | The Gold Cylinder is used in conjunction with | ||||||
| Regular Abutment to provide support for screw | |||||||
| type final prosthesis by casting with precious metal | |||||||
| alloy (Gold alloy). It is connected to the Abutment | |||||||
| using Abutment Screw. | The Gold Cylinder is used in conjunction with | ||||||
| Abutment to provide support for screw type final | |||||||
| prosthesis by casting with precious metal alloy | |||||||
| (Gold alloy). It is connected to the Abutment using | |||||||
| the Screw. | |||||||
| Substantial Equivalence Discussion |
Similarities 1.
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, Surface -Treatment, Single Use, Sterilization and Principle of Operation.
Differences 2.
- N/A -
- ന് Discussion
- The proposed Gold Cylinder had been FDA cleared with 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 straight type.
35
1. Similarities
The subject device has the same characteristic for the followings compared to the reference device 1.
Indication for use, Design, Angulation, Material, Surface Treatment, Single Use, Sterilization and Principle of l Operation
- Differences
The subject device has the different characteristic for the followings compared to the reference device 1.
- Diameter, Total Length, Post Height, Gingival (Cuff) Height י
The diameter, Total length and Gingival (cuff) Height of subject device is slightly different with reference device 1 but all the dimensions of subject device lie within range of reference devices. The subject device has same Post Height as predicate for P.H 10.0mm. The only difference is that slight (13.0mm) is added in the subject
36
device, but the Total Length of subject device lie within combined range of reference devices. Also, 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.
-Connection Interface
The subject device has Hex / Non-Hex connection while the reference device 1 has Octa / Non-Octa connection.
However, the connection difference can be covered by the referenc provides anti-rotational feature and multiple predicate & reference devices for Hex / Non-Hex are already presented in the other component comparison charts.
ന് Discussion
The proposed CCM Cylinder is being submitted to add in Megagen's existing prosthetic portfolio which had been FDA cleared. Therefore, the proposed CCM Cylinder and reference device 1 have common in Indication for use, Design, Angulation, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is straight type.
37
| Cylinder Screw | ||||
|---|---|---|---|---|
| -- | ---------------- | -- | -- | -- |
| Subject Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | |
|---|---|---|---|---|
| 510(k) No. | K203554 | K052369 | K053353 | K123988 |
| Device Name | Cylinder Screw | |||
| For AnyOne External | ||||
| Implant System | Cylinder Screw | |||
| For ExFeel Dental Implant | ||||
| System | Cylinder Screw | |||
| For Rescue Dental Implant | ||||
| System | Flat Cylinder Screw | |||
| For AnyOne Internal | ||||
| 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 External | |||
| 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 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 Rescue® 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. | ||||
| These implants are | ||||
| intended to be used where | ||||
| smaller implants have | ||||
| failed. | 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: screw | Image: screw | Image: screw | Image: screw |
| Diameter (Ø) | 2.0 mm | 2.5 mm | 2.9 | 2.1 mm |
| Total Length | 3.4 mm | 4.85 mm | 4.2 mm | 5.9 mm |
| Connection | ||||
| Interface | Internal Conical | |||
| Connection | Internal Conical | |||
| Connection | Internal Conical | |||
| Connection | Internal Conical | |||
| Connection | ||||
| Material | Ti-6A1-4V ELI | |||
| (ASTM F136-13) | CP Ti Grade 3 | |||
| (ASTM F67-13) | CP Ti Grade 3 | |||
| (ASTM F67-13) | Ti-6A1-4V ELI | |||
| (ASTM F136-13) | ||||
| Surface | ||||
| Treatment | Machined | Machined | Machined | Machined |
| Single Use | Yes | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Principle of | ||||
| Operation | The Cylinder Screw is used | |||
| for connecting Multi-unit | ||||
| (Angled) Abutment to | ||||
| Healing Cap, Temporary | ||||
| Cylinder or CCM Cylinder. | The Cylinder Screw is used | |||
| for connecting Abutment to | ||||
| Healing Cap or Cylinder. | The Cylinder Screw is used | |||
| for connecting Abutment to | ||||
| Healing Cap or Cylinder. | The Flat Cylinder Screw is | |||
| used for connecting | ||||
| Abutment to Healing Cap or | ||||
| Cylinder. | ||||
| Substantial Equivalence Discussion | ||||
| 1. | Similarities | |||
| Subject Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | |
| 510(k) No. | K203554 | K182448 | K182091 | K192614 |
| Device Name | ||||
| (Compatible | ||||
| Implant System) | Meg-Rhein Abutment | |||
| For AnyOne External | ||||
| Implant System | Meg-Rhein Abutment | |||
| For AnyRidge Octa 1 | ||||
| Implant System | Port Abutment | |||
| For Osstem Abutment | ||||
| System | Meg-Magnet Abutment | |||
| For Meg-Ball Attachment | ||||
| System, Meg-Loc | ||||
| Abutment, | ||||
| Meg-Magnet Abutment | ||||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | OSSTEM IMPLANT Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | ||||
| Use Statement | The AnyOne External | |||
| 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 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. | 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) | 2.5 mm | 2.5 mm | Not Known | N/A |
| Head Height | ||||
| (Post Height) | 1.7 mm | 1.7 mm | Not Known | N/A |
| Diameter (Ø) | 3.5, 4.1, 5.0 mm | 2.907, 3.407 mm | 3.5, 3.7, 4.1, 4.8, 5.1 | |
| mm | 4.5, 5.0mm | |||
| Total Length | 7.9, 9.9, 11.9 mm | 8.3, 8.8, 9.8, 10.8, 11.8, | ||
| 12.8, 13.8 mm | Not Known | 5.65 – 11.4 mm | ||
| Gingival | ||||
| Height | 2.0, 4.0, 6.0 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 | 0.3, 0.8, 1.8, 2.8, 3.8, | |||
| 4.8, 5.8mm | ||||
| Angulation | Straight | Straight | Straight | Straight |
| Connection | ||||
| Interface | Internal Conical | |||
| Connection | Internal Conical | |||
| Connection | Internal Conical | |||
| Connection | Internal Conical | |||
| Connection | ||||
| Material | Ti-6A1-4V ELI | |||
| (ASTM F136-13) | Ti-6Al-4V ELI | |||
| (ASTM F136-13) | Ti-6Al-4V ELI | |||
| (ASTM F136-13) | Stainless Steel | |||
| (ASTM F899-09) | ||||
| 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 | ||||
| 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. |
The subject device has the same characteristic for the followings compared to the reference device 1.
- Indication for use, Design, Connection Interface, Surface Treatment, Single Use, Sterilization and Principle of -Operation
Differences
- The subject device has the different characteristic for the followings compared to the reference device 1.
- Diameter, Total Length -
- The Diameter and Total Length of subject device is slightly different with reference devices but 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.
- -Material
- The subject device is made of titanium alloy while the reference device 1 is made entirely of commercially pure titanium, but has made with same material with reference device 3. Also, the leveraged materials are being used for similar devices and intended uses.
ന് Discussion
- The proposed Cylinder Screw is being submitted to add in Megagen's existing prosthetic portfolio which had been -FDA cleared. Therefore, the proposed Cylinder Screw and reference device 1 have common in Indication for use, Design, Connection Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence.
38
Meg-Rhein Abutment
39
| Substantial Equivalence Discussion | |
|---|---|
| 1. | Similarities |
| The subject device has the same characteristic for the followings compared to the reference device 1. |
- Indication for use, Design, Head Diameter, Head Height (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 1. - Diameter, Total Length, Gingival Height
- The Diameter, Total Length and Gingival Height of subject device is slightly different with reference device 1 but all the dimensions of subject device lie within combined range of reference devices.
- Surface Treatment
- Surface Treatment
- The subject device is treated with partial Tin Coating in upper part while the predicate device 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 Megagen's existing prosthetic portfolio which had been FDA cleared as with reference device 1. Therefore, the proposed Meg-Rhein Abutment and reference device 1 have common in Indication for use, Design, Head Diameter, Head Height (Post Height), Angulation, Connection Interface, Material, Single Use, Sterilization and Principle of Operation. The 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 the overdenture that means load is dispersed to the full denture. |
40
8. Summary of Non-Clinical Testing
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 External Implant System since AnyOne External Implant System has same material composition, manufacturing process and patient contacting parts as predicate device, XPEED AnyRidge Internal Implant System (K122231) for the Fixture, and ST Internal Implant System (K192347), AnyOne Internal Implant System (K123988), AnyRidge Octa 1 Implant System (K182448) and Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment (K19614) for the Abutment.
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 External Implant System has same surface treatment and manufacturing process as predicate device, XPEED AnyRidge Internal Implant System (K122231) for the surface treatment of S.L.A (Fixture), ST Internal Implant System(K192347) for the Anodizing method (Abutment), and Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment (K19614) for TiN coating (Abutment).
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.
- י Static compression-strength test
- . Fatigue test
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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 External Implant System is substantially equivalent to the predicate device as herein.