(152 days)
The AnyOne Onestage Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following stuations and with the clinical protocols:
-Delayed loading.
-Immediate loading when good
primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region.
AnyOne Onestage Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients and consists of fixtures and abutments. The dental implants which used in conjunction with other prosthesis restore the lost chewing ability and improve the appearance.
AnyOne Onestage Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the . surface treated by SLA method. It is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity. The fixtures have Octa connection, and various cuff height with consideration for soft tissue level (gingival height). These fixtures can be used the one-stage and two-stage surgical procedure. This device is a tissue level implant.
Dental prosthesis is an abutment of a dental implant system and connecting elements between the dental implant and the restoration. The abutment is fixed to the implant and is permanently or temporary in contact with the gum in the surgical cavity. These abutments are made of alloy and POM, and intended to be placed on the fixture allows single & multiple prosthetic restorations to restore a patient's chewing function.
The proposed AnyOne Onestage Implant System is consisted of the following components: Fixture Products (AnyOne Onestage Fixture), Closing Screw & Cover Screw & Healing Abutment (Closing Screw, Cover Screw, Healing Abutment), Fixture Level Prosthesis (Multi Post, Multi Post Cap, EZ Post Abutment, Angled Abutment, Gold Abutment, CCM Abutment, Multi Post Screw, Abutment Screw), Abutment Level Prosthesis (Solid Abutment, Solid Cap, Solid Post Abutment, Solid Post Cap, Octa Abutment, Healing Cap, Temporary Cylinder, EZ Post Cylinder, Gold Cylinder, CCM Cylinder, Abutment Screw), Overdenture Prosthesis (Meg-Loc Abutment, Meg-Ball Abutment, Meg-Magnet Abutment, Magnet, Meg-Rhein Abutment).
The provided text does not describe an AI/ML device but rather a dental implant system. Therefore, details regarding AI/ML device performance, such as acceptance criteria, test set sample size, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or training set specifics, are not applicable and not present in the document.
The document focuses on demonstrating the substantial equivalence of the "AnyOne Onestage Implant System" to predicate devices, primarily through comparison of design, materials, indications for use, and mechanical performance testing (biocompatibility, surface treatment, endotoxin, sterilization, and static/fatigue tests).
Acceptance Criteria and Device Performance (Not Applicable for AI/ML):
Since this is a non-AI/ML device, the concept of "acceptance criteria" as it relates to algorithm performance (e.g., sensitivity, specificity, AUC) and "reported device performance" in that context is not relevant. Instead, the document demonstrates that the new device meets established standards and is equivalent to legally marketed predicate devices through various non-clinical tests.
However, if we interpret "acceptance criteria" as the criteria for demonstrating substantial equivalence for this medical device (dental implant system) and "reported device performance" as the results of the non-clinical tests, we can extract details regarding the physical property tests performed. The acceptance criterion for these tests is that the device must meet "pre-set criteria" according to ISO 14801 and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment," and the reported performance is simply that the test results "met the pre-set criteria."
Summary of Non-Clinical Testing Performance for Dental Implant System:
| Acceptance Criteria (Met by) | Reported Device Performance |
|---|---|
| Biocompatibility: In accordance with ISO 10993-1. | "Additional biocompatibility testing is not required... since AnyOne Onestage Implant System has same material composition, manufacturing process and patient contacting parts as predicate device." |
| Modified Surface Treatment: In accordance with 'Section 11 of Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'. | "AnyOne Onestage Implant System has same surface treatment and manufacturing process as predicate device" for SLA, Anodizing, and TiN coating. |
| Pyrogen and Endotoxin Test: "Not be labeled as 'non-pyrogenic'", endotoxin testing conducted on every batch with a testing limit below 0.5 EU/mL in accordance with USP 39 <85>. | "endotoxin testing will be conducted on every batch... with the testing limit of below 0.5 EU/mL". |
| Sterilization Validation: In accordance with ISO 11137 and ISO 17665-1, 2 to verify sterility assurance level (10^-4^). Accelerated aging method in accordance with ASTM F1980 to validate shelf life. | Tests validated a 5-year shelf life. Sterilization validation met SAL (10^-4^). |
| Performance (Physical Properties) Test: "Pre-set criteria" according to "ISO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment" for static compression-strength test and fatigue test. | "The test results met the pre-set criteria." |
Further details as requested (adapted for a non-AI/ML device):
-
Sample size used for the test set and the data provenance:
The document focuses on non-clinical (bench) testing. For the physical properties (static compression-strength and fatigue tests), representative specimens were selected "under the consideration of worst case." The exact number of samples tested for each component is not explicitly stated in this summary, but it would have been part of the full testing report. The provenance of the "data" would be the internal testing laboratories of MegaGen Implant Co., Ltd. (Republic of Korea). The tests are prospective in the sense that they are specifically conducted to support this 510(k) submission. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical tests is established by standardized testing protocols (e.g., ISO 14801) and engineering measurements, not human expert consensus.
-
Adjudication method for the test set: Not applicable for physical property testing. Test results are objectively measured against predefined standards.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a dental implant system (physical device), not an AI/ML diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
-
The type of ground truth used:
For physical properties (static compression-strength and fatigue), the "ground truth" is based on the performance requirements specified in international standards (ISO 14801) and FDA guidance documents ("Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment"). For biocompatibility and sterilization, it's adherence to ISO standards (ISO 10993-1, ISO 11137, ISO 17665-1, 2) and ASTM standards (ASTM F1980), as well as USP <85> for endotoxin. -
The sample size for the training set: Not applicable, as this is not an AI/ML device.
-
How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
MegaGen Implant Co., Ltd. % You Kim Chief Researcher DaeGyeong Regulatory Affairs Institute 32. Innovallev-ro Daegu, Dong-gu 41065 REPUBLIC OF KOREA
Re: K210161
Trade/Device Name: AnyOne Onestage Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 20, 2021 Received: May 24, 2021
Dear You Kim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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
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Indications for Use
510(k) Number (if known) K210161
Device Name AnyOne Onestage Implant System
The AnyOne Onestage Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following stuations and with the clinical protocols:
-Delayed loading.
-Immediate loading when good
primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------ |
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510(k) Summary for K210161
Date: June 22, 2021
1. Applicant / Submitter
MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun, Daegu, Republic of Korea Tel: + 82-53-222-2828
2. Submission Correspondent
You Jung Kim DaeGyeong Regulatory affairs Institute 32, Innovalley-ro, Dong-gu, Daegu, 41065, Republic of Korea Tel: +82-53-247-2258 Fax: +82-53-247-2254 Email: ra3@dgri.co.kr
3. Device
- Trade Name: AnyOne Onestage Implant System ■ Common Name: Endosseous Dental Implant ■ Classification Name: Endosseous dental implant ■ Classification Product Code: DZE ■ Secondary Product Code: NHA ■ Classification regulation: Class II, 21 CFR 872.3640
Predicate Device 4.
. Primary Predicate Device: K182448- AnyRidge Octa 1 Implant System
. Reference Devices:
K052369 - ExFeel Dental Implant System K150537 - MiNi Internal Implant System K123988 - AnyOne Internal Implant System K160670 - ET US SS Prosthetic System K171027 - Dentis Dental Implant System K192614 - Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment K182091 - Osstem Abutment System
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5. Description
- AnyOne Onestage Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients and consists of fixtures and abutments. The dental implants which used in conjunction with other prosthesis restore the lost chewing ability and improve the appearance.
- AnyOne Onestage Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the . surface treated by SLA method. It is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity. The fixtures have Octa connection, and various cuff height with consideration for soft tissue level (gingival height). These fixtures can be used the one-stage and two-stage surgical procedure. This device is a tissue level implant.
- . Dental prosthesis is an abutment of a dental implant system and connecting elements between the dental implant and the restoration. The abutment is fixed to the implant and is permanently or temporary in
contact with the gum in the surgical cavity. These abutments are made of alloy and POM, and intended to be placed on the fixture allows single & multiple prosthetic restorations to restore a patient's chewing function. - The proposed AnyOne Onestage Implant System is consisted of the following components. For reference, . all the subject device in this submission are to be added Megagen's existing implant and prosthetic portfolio which had been FDA cleared.
| Content | |||
|---|---|---|---|
| 1. Fixture Products | AnyOne Onestage Fixture | Description AnyOne Onestage Fixture is a substructure of a dental implant system made of titanium and have the interface connection for Internal Octa. It is used in conjunction with other prosthetic and restore lost chewing ability, improve appearance. | |
| Material CP Ti Grade 4 (ASTM F67-13) | |||
| Dimension (Diameter & Length) Ø 3.9 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mmØ 4.3 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mmØ 4.8 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mmØ 5.3 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm | |||
| Gingival (Cuff) Height 1.2, 1.8, 2.2 mm | |||
| 2. Closing Screw & Cover Screw & Healing Abutment | Closing Screw | Description The Closing Screw is used in conjunction with fixture for protecting the inner structure of a fixture, and exposed fixture platform after fixture placement. | |
| Material Ti-6Al-4V ELI (ASTM F136-13) | |||
| Dimension (Diameter & Length) Ø 3.5 x 6.0 mm | |||
| Gingival (Cuff) Height 1.5mm | |||
| Angulation Straight | |||
| Cover Screw | Description The Cover Screw is used in conjunction with fixture for protecting the inner structure of a fixture, and exposed fixture platform after fixture placement. | ||
| Material Ti-6Al-4V ELI (ASTM F136-13) | |||
| Dimension (Diameter & Length) Ø 4.85 x 7.0 mm | |||
| Gingival (Cuff) Height 1.5mm | |||
| Angulation Straight | |||
| Healing Abutment | Description The Healing Abutment is used in conjunction with fixture and helps to form suitable emergence profile during period of gingival healing. | ||
| Material Ti-6Al-4V ELI (ASTM F136-13) | |||
| Dimension (Diameter & Length) Ø 5.5 x 6.5, 7.5, 8.5 mm | |||
| Gingival (Cuff) Height 2.0, 3.0, 4.0 mm | |||
| Angulation Straight | |||
| 3. Fixture Level Prosthesis | Multi Post | Description The Multi Post is used in conjunction with fixture to provide support for cement retained type final prosthesis. It is connected to the Fixture using Multi Post Screw. | |
| Material Ti-6Al-4V ELI (ASTM F136-13) | |||
| Dimension (Diameter & Length) Ø 5.5 x 8.7 mm | |||
| Gingival (Cuff) Height | 1.0 mm | ||
| Post Height | 5.5 mm | ||
| Angulation | Straight | ||
| Multi PostCap | Description | The Multi Post Cap is used to protect Multi Post, minimizesdiscomfort of oral cavity and relieve feeling of irritation andprotect until the prosthesis is produced after the impressionis taken. | |
| Material | POM | ||
| Dimension(Diameter & Length) | Ø 5.9 x6.5 mm | ||
| Post Height | 5.5 mm | ||
| EZ PostAbutment | Description | The EZ Post Abutment is used in conjunction with fixture toprovide support for cement and screw retained type finalprosthesis. It is connected to the Fixture using Multi PostScrew. | |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | ||
| Dimension(Diameter & Length) | Ø 4.8 x 6.2, 7.2,10) 7.7, 8.2, 8.7, 9.2, 9.7, 10.2, 10.7, 11.2, 12.2mm | ||
| Gingival (Cuff) Height | 0.0, 1.0, 2.0, 3.0 mm | ||
| Post Height | 4.0, 5.5, 7.0 mm | ||
| Angulation | Straight | ||
| AngledAbutment | Description | The Angled Abutment is used in conjunction with fixture andused for correcting the prosthetic angulation of implant. It isconnected to the Fixture using Abutment Screw. | |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | ||
| Dimension(Diameter & Length) | Ø 3.7 x 9.0 mm | ||
| Post Height | 6.5 mm | ||
| Angulation | 15°, 25° | ||
| GoldAbutment | Description | The Gold Abutment is used in conjunction with fixture andused for fabrication of abutment for either screw or cementretained restorations by casting with precious metal alloy(Gold alloy). It is connected to the Fixture using Multi PostScrew. | |
| Material | Body: Gold Alloy / Sleeve: POM | ||
| Dimension(Diameter & Length) | Ø 5.5 x 13.65 mm | ||
| Gingival (Cuff) Height | 1.5 mm | ||
| Post Height | 10.0 mm | ||
| Angulation | Straight | ||
| CCMAbutment | Description | The CCM Abutment is used in conjunction with fixture andused for fabrication of abutment for either screw or cementretained restorations by casting with non-precious metalalloy (Co-Cr-Mo alloy). It is connected to the Fixture usingMulti Post Screw. | |
| Material | Body: Co-Cr-Mo Alloy / Sleeve: POM | ||
| Dimension(Diameter & Length) | Ø 5.5 x 13.65 mm | ||
| Gingival (Cuff) Height | 1.5 mm | ||
| Post Height | 10.0 mm | ||
| Angulation | Straight | ||
| Multi PostScrew | Description | The Multi Post Screw is used for connecting Fixture to MultiPost, EZ Post Abutment, Gold Abutment or CCM Abutment | |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | ||
| Dimension(Diameter & Length) | Ø 2.5 x 8.1 mm | ||
| AbutmentScrew | Description | The Abutment Screw is used for connecting Fixture to AngledAbutment. | |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | ||
| Dimension(Diameter & Length) | Ø 2.6 x 5.5 mm | ||
| 4. AbutmentLevelProsthesis | SolidAbutment | Description | The Solid Abutment is used in conjunction with fixture toprovide support for final prosthesis, and used in cementretained restoration only. It is connected to the Fixture by itsthreaded part. |
| Material | Ti-6Al-4V ELI (ASTM F136-13) |
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| (Diameter & Length) | ||||||
|---|---|---|---|---|---|---|
| Post Height | 4.0, 5.5, 7.0 mm | |||||
| Angulation | Straight | |||||
| Solid Cap | Description | The Solid Cap is used for protecting a Solid Abutment after taking impression, and minimizing irritation to tongue and oral mucosa. | ||||
| Material | POM | |||||
| Dimension | Ø 5.7 x 6.5, 8.0, 9.5 mm | |||||
| (Diameter & Length) | ||||||
| Post Height | 4.0, 5.5, 7.0 mm | |||||
| Solid PostAbutment | Description | The Solid Post Abutment is used in conjunction with fixture to provide support for final prosthesis, and used in cement retained restoration only. It is connected to the Fixture by its threaded part. | ||||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | |||||
| Dimension | Ø 4.9 x 9.5, 10.5, 11.0, 11.5, 12.0, 12.5, 13.0, 13.5, 14.5 mm | |||||
| (Diameter & Length) | ||||||
| Gingival (Cuff) Height | 1.0, 2.0, 3.0 mm | |||||
| Post Height | 4.0, 5.5, 7.0 mm | |||||
| Angulation | Straight | |||||
| Solid PostCap | Description | The Solid Post Cap is used for protecting a Solid Post Abutment after taking impression, and minimizing irritation to tongue and oral mucosa. | ||||
| Material | POM | |||||
| Dimension | Ø 5.3 x 6.5, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0, 10.5, 11.5 mm | |||||
| (Diameter & Length) | ||||||
| Gingival (Cuff) Height | 1.0, 2.0, 3.0 mm | |||||
| Post Height | 4.0, 5.5, 7.0 mm | |||||
| OctaAbutment | Description | The Octa Abutment is used in conjunction with fixture for fabricating screw-retained prosthesis. It is connected to the Fixture by its threaded part. | ||||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | |||||
| Dimension | Ø 3.5 x 6.5 mm | |||||
| (Diameter & Length) | ||||||
| Post Height | 1.5 mm | |||||
| Angulation | Straight | |||||
| Healing Cap | Description | The Healing Cap is used for protecting Octa Abutment and minimizing irritation to tongue and oral mucosa during period of gingival healing. It is connected to the Octa Abutment using Abutment Screw. | ||||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | |||||
| Dimension | Ø 5.2 x 4.0 mm | |||||
| (Diameter & Length) | ||||||
| TemporaryCylinder | Description | The Temporary Cylinder is used in conjunction with Octa Abutment to provide support for provisional restoration. It is connected to the Octa Abutment using Abutment Screw. | ||||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | |||||
| Dimension | Ø 5.0 x 10.0 mm | |||||
| (Diameter & Length) | ||||||
| Post Heights | 7.0 mm | |||||
| Angulation | Straight | |||||
| EZ PostCylinder | Description | The EZ Post Cylinder is used in conjunction with Octa Abutment to provide support for cement and screw type final prosthesis. It is connected to the Octa Abutment using Abutment Screw. | ||||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | |||||
| Dimension | Ø 5.0 x 5.5, 7.0 mm | |||||
| (Diameter & Length) | ||||||
| Post Heights | 5.5, 7.0 mm | |||||
| Angulation | Straight | |||||
| Gold | Gold Cylinder | Description | The Gold Cylinder is used in conjunction with Octa Abutment | The Gold Cylinder is used in conjunction with Octa Abutment to provide support for screw type final prosthesis by casting with precious metal alloy (Gold alloy). It is connected to the Octa Abutment using Abutment Screw. | ||
| Material | Body: Gold Alloy / Sleeve: POM | |||||
| Dimension(Diameter & Length) | $Ø$ 5.1 x 12.0 mm | |||||
| Post Heights | 10.0 mm | |||||
| Angulation | Straight | |||||
| CCM Cylinder | Description | The CCM Cylinder is used in conjunction with Octa Abutmentto provide support for screw type final prosthesis by castingwith non-precious metal alloy (Co-Cr-Mo alloy). It isconnected to the Octa Abutment using Abutment Screw. | ||||
| Material | Body: Gold Alloy / Sleeve: POM | |||||
| Dimension(Diameter & Length) | $Ø$ 5.1 x 12.0 mm | |||||
| Post Heights | 10.0 mm | |||||
| Angulation | Straight | |||||
| AbutmentScrew | Description | The Abutment Screw is used for connecting the OctaAbutment to the Healing Cap, Temporary Cylinder, EZ PostCylinder, Gold Cylinder or CCM Cylinder. | ||||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | |||||
| Dimension(Diameter & Length) | $Ø$ 2.5 x 4.85 mm | |||||
| 5. OverdentureProsthesis | Meg-LocAbutment | Description | The Meg-Loc Abutment is used in conjunction with fixtureand intended to be connected to an overdenture to allow itsinsertion and removal with its attachment (K151789). It isconnected to the Fixture using its threaded part. | |||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | |||||
| Dimension(Diameter & Length) | $Ø$ 3.89 x 7.45, 7.95, 8.95, 9.95, 10.95, 11.95, 12.95, 13.95 mm | |||||
| Gingival (Cuff) Height | 0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8, 6.8 mm | |||||
| Post Height | 1.5 mm | |||||
| Angulation | Up to 20° | |||||
| Meg-BallAbutment | Description | The Meg-Ball Abutment is used in conjunction with fixtureand intended to be connected to an overdenture to allow itsinsertion and removal with its attachment (K192614). It isconnected to the Fixture using its threaded part. | ||||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | |||||
| Dimension(Head Diameter &Head Length) | $Ø$ 2.25 x 4.15 mm | |||||
| Dimension(Diameter & Length) | $Ø$ 3.5 x 10.1, 10.6, 11.6, 12.6, 13.6, 14.6, 15.6, 16.6 mm | |||||
| Gingival (Cuff) Height | 0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8, 6.8 mm | |||||
| Post Height | 4.15 mm | |||||
| Angulation | Up to 15° | |||||
| Meg-MagnetAbutment | Description | The Meg-Magnet Abutment is used in conjunction withfixture and intended to be connected to an overdenture toallow its insertion and removal using the magnetic force ofmagnet attachment. It is connected to the Fixture using itsthreaded part. | ||||
| Material | Stainless Steel (ASTM F899-20) | |||||
| Dimension(Diameter & Length) | $Ø$ 4.5 x 6.20, 6.25, 6.75, 7.20, 7.75, 8.20, 8.75, 9.20, 9.75,10.20, 10.75, 11.20, 11.75, 12.20, 12.75 mm$Ø$ 5.0 x 6.20, 6.25, 6.75, 7.20, 7.75, 8.20, 8.75, 9.20, 9.75,10.20, 10.75, 11.20, 11.75, 12.20, 12.75 mm | |||||
| Gingival (Cuff) Height | 0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8, 6.8 mm | |||||
| Angulation | Straight | |||||
| Meg-MagnetAbutment | Magnet | Dimension(Diameter & Length) | Description | $Ø$ 3.5 x 10.1, 10.6, 11.6, 12.6, 13.6, 14.6, 15.6, 16.6 mm | The Magnet is used in fixed overdenture restorations andapplied with Meg-Magnet Abutment to stabilize theoverdenture using its magnetic force. | |
| Gingival (Cuff) Height | 0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8, 6.8 mm | |||||
| Post Height | 4.15 mm | |||||
| Angulation | Up to 15° | |||||
| Description | The Meg-Magnet Abutment is used in conjunction withfixture and intended to be connected to an overdenture toallow its insertion and removal using the magnetic force ofmagnet attachment. It is connected to the Fixture using itsthreaded part. | |||||
| Material | Stainless Steel (ASTM F899-20) | |||||
| Magnet | Dimension(Diameter & Length) | $Ø$ 4.5 x 6.20, 6.25, 6.75, 7.20, 7.75, 8.20, 8.75, 9.20, 9.75,10.20, 10.75, 11.20, 11.75, 12.20, 12.75 mm$Ø$ 5.0 x 6.20, 6.25, 6.75, 7.20, 7.75, 8.20, 8.75, 9.20, 9.75,10.20, 10.75, 11.20, 11.75, 12.20, 12.75 mm | ||||
| Gingival (Cuff) Height | 0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8, 6.8 mm | |||||
| Angulation | Straight | |||||
| Description | The Magnet is used in fixed overdenture restorations andapplied with Meg-Magnet Abutment to stabilize theoverdenture using its magnetic force. | |||||
| Material | Stainless Steel (ASTM F899-20) | |||||
| Meg-RheinAbutment | Dimension(Diameter & Length) | $Ø$ 4.5 x 2.2 mm$Ø$ 5.0 x 2.2 mm | ||||
| Description | The Meg-Rhein Abutment is used in conjunction with fixtureand intended to be connected to an overdenture to allow itsinsertion and removal with its attachment (K171409). It isconnected to the Fixture using its threaded part. | |||||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | |||||
| Dimension(Diameter & Length) | $Ø$ 3.5 x 7.45, 9.15, 11.15, 13.15 mm | |||||
| Gingival (Cuff) Height | 0.3, 2.0, 4.0, 6.0mm | |||||
| Post Height | 1.7 mm | |||||
| Angulation | Straight |
{7}------------------------------------------------
{8}------------------------------------------------
| Changes are explained not affecting substantial equivalence in this 510(k) Submission. | ||||||
|---|---|---|---|---|---|---|
| Predicate Device | Subject Device | |||||
| No. | 510(k) No. | Product Name | Material | Product Name | Material | Change |
| 1 | K052369 | Closing Screw | CP Ti Grade 3 | Closing Screw | Ti-6Al-4V ELI | - Material |
| 2 | K052369 | Cover Screw | CP Ti Grade 3 | Cover Screw | Ti-6Al-4V ELI | - Material |
| 3 | K052369 | Healing Abutment | CP Ti Grade 3 | Healing Abutment | Ti-6Al-4V ELI | - Material |
| 4 | K052369 | ExFeel Internal Multi-mount | CP Ti Grade 3 | Multi Post | Ti-6Al-4V ELI | - Product Name- Material |
| 5 | K052369 | ExFeel Internal Multi-mount Cap | No Change | Multi Post Cap | No Change | - Product Name |
| 6 | K052369 | ExFeel Internal Screw | No Change | Multi Post Screw | No Change | - Product Name |
| 7 | K052369 | Solid Abutment | CP Ti Grade 3 | Solid Abutment | Ti-6Al-4V ELI | - Material |
| 8 | K052369 | Solid Protect Cap | No Change | Solid Cap | No Change | - Product Name |
| 9 | K123988 | Octa Healing Cap | No Change | Healing Cap | No Change | - Product Name |
| 10 | K123988 | Temporary Cylinder | CP Ti Grade 4 | Temporary Cylinder | Ti-6Al-4V ELI | - Material |
| 11 | K123988 | EZ Post Cylinder | CP Ti Grade 4 | EZ Post Cylinder | Ti-6Al-4V ELI | - Material |
[Note. 1] Some of devices described in this submission had been FDA cleared with K052369 and it is being submitted to change their identifier with modification of product name or material as followings. The od not affecting substantial equivalence in this 510(k) Submis cha : ﻣﺎﻟﻤ
[Note. 2] Some of overdenture prosthesis described in this submission had been FDA cleared with K192614, but it is being submitted to change their identifier with modification of surface treatment or compatible implant system as followings. The changes are explained not affecting substantial equivalence in this 510(k) Submission.
Abutment Screw
No Change
- Product Name
No Change
Octa Abutment
Screw
12
| No. | Predicate Device | Subject Device | ||||||
|---|---|---|---|---|---|---|---|---|
| 510(k)No. | ProductName | SurfaceTreatment | ImplantSystem | ProductName | SurfaceTreatment | ImplantSystem | Change | |
| 1 | K192614 | Meg-LocAbutment | Machined | ExFeelDentalImplantSystem(K052369) | Meg-LocAbutment | TiNCoating | AnyOneOnestageImplantSystem | - Surface Treatment- Implant System |
| 2 | K192614 | Meg-BallAbutment | NoChange | ExFeelDentalImplantSystem(K052369) | Meg-BallAbutment | NoChange | AnyOneOnestageImplantSystem | - Implant System |
| 3 | K192614 | Meg-MagnetAbutment | NoChange | ExFeelDentalImplantSystem(K052369) | Meg-MagnetAbutment | NoChange | AnyOneOnestageImplantSystem | - Implant System |
{9}------------------------------------------------
6. Indication for use
The AnyOne Onestage Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:
-Delayed loading.
-Immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region.
7. Basis for Substantial Equivalence
The AnyOne Onestage Implant System is substantially equivalent to the predicate devices in terms of indication for use, technical characteristic and function. They are made of the same material and have similar design.
The Indications for Use for the subject devices is identical to the primary predicate, K182448.
In order to demonstrate the difference in design does not raise any new issues, the performance test on the subject and predicate device have been performed in consideration of the worst case according to 'ISO 14801' and 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment' to figure out the physical property. The test result supports the substantial equivalence to the predicate devices.
Based on the comparison charts below and test results provided in this submission, we conclude that the subject device is substantially equivalent to the predicate devices.
{10}------------------------------------------------
AnyOne Onestage Fixture
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K210161 | K182448 | K052369 |
| Device Name(CompatibleImplantSystem) | AnyOne Onestage FixtureFor AnyOne Onestage ImplantSystem | AnyRidge Octa 1 FixtureFor AnyRidge Octa 1 ImplantSystem | ExFeel Internal FixtureFor ExFeel Dental Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | The AnyOne Onestage ImplantSystem is intended to besurgically placed in the maxillaryor mandibular arches for thepurpose of providing prostheticsupport for dental restorations(Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is usedto restore a patient's chewingfunction in the followingsituations and with the clinicalprotocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved andwith appropriate occlusal loading.Larger implants are dedicated forthe molar region. | The AnyRidge Octa 1 ImplantSystem is intended to besurgically placed in the maxillaryor mandibular arches for thepurpose of providing prostheticsupport for dental restorations(Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is usedto restore a patient's chewingfunction in the followingsituations and with the clinicalprotocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved andwith appropriate occlusal loading.Larger implants are dedicated forthe molar region. | The ExFeel Dental ImplantSystems are intended to beplaced in the upper or lower jawto support prosthetic devices,such as artificial teeth, and torestore a patient's chewingfunction. This may beaccomplished using either a twostage surgical procedure or asingle stage surgical procedure. |
| Design | Image: AnyOne Onestage Fixture | Image: AnyRidge Octa 1 Fixture | Image: ExFeel Internal Fixture |
| Diameter (Ø) | 3.9, 4.3, 4.8, 5.3 mm | 3.6, 4.0, 4.4, 4.7, 4.8, 5.0,5.5mm | 3.5, 4.1, 4.8 mm |
| Length | 7.0, 8.0, 9.5, 11.0, 12.5, 14.5mm | 7.0, 7.7, 9.2, 10.7, 12.2, 14.2,17.2mm | 7.0, 8.5, 10.0, 11.5, 13.0 mm |
| Gingival (Cuff)Height | 1.2, 1.8, 2.2 mm | N/A | 2.2 mm |
| Implant-toAbutmentConnection | Internal Octa | Internal Octa | Internal Octa |
| Material | CP Ti Grade 4 (ASTM F67-13) | CP Ti Grade 4 (ASTM F67-13) | CP Ti Grade 4 (ASTM F67-13) |
| Single Use | Yes | Yes | Yes |
| SurfaceTreatment | Sand-blasted, Large grit, Acid-etched (SLA) andPartial Anodizing in upper part | Sand-blasted, Large grit, Acid-etched (SLA) | Sand-blasted (RBM) andPartial Anodizing in upper part |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Shelf Life | 5 years | 5 years | 5 years |
| Feature | - Straight / Tapered body shape- cutting edge with self-tapping- 0.8mm thread pitch | - Straight / Tapered body shape- cutting edge with self-tapping- 0.8mm thread pitch | - Straight / Root form shape- cutting edge with self-tapping- 1.25mm thread pitch |
| Principle ofOperation | It is a tapered body fixture whichis inserted in the alveolar bone. Itreplaces the functions of themissing teeth as a dental implantfixture. | It is a tapered body fixture whichis inserted in the alveolar bone. Itreplaces the functions of themissing teeth as a dental implantfixture. | It is a root form fixture which isinserted in the alveolar bone. Itreplaces the functions of themissing teeth as a dental implantfixture. |
1. Similarities
The subject device has the same characteristic for the followings compared to the predicate device.
Indication for use, Design, Connection, Material, Single Use, Sterilization, Shelf Life, Feature and Principle of Operation.
2. Differences
The subject device has the different characteristic for the followings compared to the predicate device.
Diameter & Length ।
The Diameter and Length of subject device is slightly different with predicate device but all the dimensions of subject device lie within the range of predicate device and reference device.
-Gingival (Cuff) Height
The subject device has cuff height with consideration for soft tissue level while the predicate device is not applicable but the reference device has a cuff height. Also, the total length of subject device including the cuff height lie within the range of predicate device and reference device, and it does not cause a matter in substantial equivalence since
{11}------------------------------------------------
the size of cuff height is very minor, the cuff height provides good gingival adaptation and the variety of the size can be possible to operate more precise treatment to meet each patient's condition.
. Surface Treatment
The general surface treatment of subject device is same as predicate device with SLA method, but the subject device is additionally treated with anodizing in upper part for good visibility of cuff height. The substantially equivalent can be explained with reference device which has same surface treatment for anodizing.
3. Discussion
The proposed AnyOne Onestage Fixture and predicate device have common in all the items in the comparison chart except the Diameter, Length, Giff) Height and Surface Treatment. These differences are explained not affecting on the substantial equivalence, but the fatigue test was performed on the subject device and predicate device to confirm the substantial equivalence, with combination of the worst case design fixture and abutment, according to "ISO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment". The test result supports that the subject device is substantially equivalent to the predicate device and the differences are not affecting the substantial equivalence. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device.
{12}------------------------------------------------
Closing Screw
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K210161 | K182448 | K052369 |
| Device Name(CompatibleImplantSystem) | Closing ScrewFor AnyOne Onestage ImplantSystem | Cover ScrewFor AnyRidge Octa 1 Implant System | Closing ScrewFor ExFeel Dental Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | The AnyOne Onestage ImplantSystem is intended to besurgically placed in the maxillaryor mandibular arches for thepurpose of providing prostheticsupport for dental restorations(Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is usedto restore a patient's chewingfunction in the followingsituations and with the clinicalprotocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved andwith appropriate occlusalloading. Larger implants arededicated for the molar region. | The AnyRidge Octa 1 ImplantSystem is intended to besurgically placed in the maxillaryor mandibular arches for thepurpose of providing prostheticsupport for dental restorations(Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is usedto restore a patient's chewingfunction in the followingsituations and with the clinicalprotocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved andwith appropriate occlusalloading. Larger implants arededicated for the molar region. | The ExFeel Dental ImplantSystems are intended to beplaced in the upper or lower jawto support prosthetic devices,such as artificial teeth, and torestore a patient's chewingfunction. This may beaccomplished using either a twostage surgical procedure or asingle stage surgical procedure. |
| Design | Image: Closing Screw | Image: Cover Screw | Image: Closing Screw |
| Diameter (Ø) | 3.5 mm | 3.0, 3.7, 5.0, 6.0 mm | 3.5 mm |
| Total Length | 6.0 mm | 6.6, 7.1 mm | 6.0 mm |
| Gingival (Cuff)Height | 1.5 mm | 0.5, 1.0 mm | 1.5 mm |
| Angulation | Straight | Straight | Straight |
| ConnectionInterface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection |
| Material | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) | CP Ti Grade 3(ASTM F67-13) |
| SurfaceTreatment | Machined | Anodizing | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Principle ofOperation | The Closing Screw is used forprotecting the inner structure ofa fixture, and exposed fixtureplatform after fixture placement. | The Cover Screw is used forprotecting the inner structure ofa fixture, and exposed fixtureplatform after fixture placement. | The Closing Screw is used forprotecting the inner structure ofa fixture, and exposed fixtureplatform after fixture placement. |
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the reference device.
Indication for use, Design, Diameter, Total Length, Gingival Height, Angulation, Connection Interface, Surface -Treatment, Single Use, Sterilization and Principle of Operation
2. Differences
The subject device has the different characteristic for the followings compared to the reference device.
Material -The subject device is made of titanium alloy while the reference device is made entirely of commercially pure titanium, but has made with same material with predicate device. Also, the multiple predicate & reference devices for titanium alloy are presented in the other component comparison charts.
- Discussion
The proposed Closing Screw had been FDA cleared with K052639, but it is being submitted to change their identifier with modification of material. Therefore, the proposed Closing Screw and reference device have common in all the items in the comparison chart except the material difference is explained not affecting on the substantial equivalence. Also, these devices were not tested for fatigue strength as they are not placed into occlusion. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device.
{13}------------------------------------------------
Cover Screw
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K210161 | K182448 | K052369 |
| Device Name(CompatibleImplantSystem) | Cover ScrewFor AnyOne Onestage ImplantSystem | Cover ScrewFor AnyRidge Octa 1 Implant System | Cover ScrewFor ExFeel Dental Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | The AnyOne Onestage ImplantSystem is intended to besurgically placed in the maxillaryor mandibular arches for thepurpose of providing prostheticsupport for dental restorations(Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is usedto restore a patient's chewingfunction in the followingsituations and with the clinicalprotocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved andwith appropriate occlusalloading. Larger implants arededicated for the molar region. | The AnyRidge Octa 1 ImplantSystem is intended to besurgically placed in the maxillaryor mandibular arches for thepurpose of providing prostheticsupport for dental restorations(Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is usedto restore a patient's chewingfunction in the followingsituations and with the clinicalprotocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved andwith appropriate occlusalloading. Larger implants arededicated for the molar region. | The ExFeel Dental Implant Systemsare intended to be placed in theupper or lower jaw to supportprosthetic devices, such as artificialteeth, and to restore a patient'schewing function. This may beaccomplished using either a twostage surgical procedure or a singlestage surgical procedure. |
| Design | Image: Subject Device Screw | Image: Primary Predicate Device Screw | Image: Reference Device Screw |
| Diameter (Ø) | 4.85 mm | 3.0, 3.7, 5.0, 6.0 mm | 4.85 mm |
| Total Length | 7.0 mm | 6.6, 7.1 mm | 7.0 mm |
| Gingival (Cuff)Height | 1.5 mm | 0.5, 1.0 mm | 1.5 mm |
| Angulation | Straight | Straight | Straight |
| ConnectionInterface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection |
| Material | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) | CP Ti Grade 3(ASTM F67-13) |
| SurfaceTreatment | Machined | Anodizing | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Principle ofOperation | The Cover Screw is used forprotecting the inner structure ofa fixture, and exposed fixtureplatform after fixture placement. | The Cover Screw is used forprotecting the inner structure ofa fixture, and exposed fixtureplatform after fixture placement. | The Cover Screw is used forprotecting the inner structure ofa fixture, and exposed fixtureplatform after fixture placement. |
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the reference device.
Indication for use, Design, Diameter, Total Length, Gingival Height, Angulation, Connection Interface, Surface -Treatment, Single Use, Sterilization and Principle of Operation
2. Differences
The subject device has the different characteristic for the followings compared to the reference device.
Material -The subject device is made of titanium alloy while the reference device is made entirely of commercially pure titanium, but has made with same material with predicate device. Also, the multiple predicate & reference devices for titanium alloy are presented in the other component comparison charts.
- Discussion
The proposed Cover Screw had been FDA cleared with K052639, but it is being submitted to change their identifier with modification of material. Therefore, the proposed Cover Screw and reference device have common in all the items in the comparison chart except the material difference is explained not affecting on the substantial equivalence. Also, these devices were not tested for fatigue strength as they are not placed into occlusion. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device.
{14}------------------------------------------------
Healing Abutment
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K210161 | K182448 | K052369 |
| Device Name(CompatibleImplantSystem) | Healing AbutmentFor AnyOne Onestage ImplantSystem | Healing AbutmentFor AnyRidge Octa 1 Implant System | Healing AbutmentFor ExFeel Dental Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | The AnyOne Onestage ImplantSystem is intended to besurgically placed in the maxillaryor mandibular arches for thepurpose of providing prostheticsupport for dental restorations(Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is usedto restore a patient's chewingfunction in the followingsituations and with the clinicalprotocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved andwith appropriate occlusalloading. Larger implants arededicated for the molar region. | The AnyRidge Octa 1 ImplantSystem is intended to besurgically placed in the maxillaryor mandibular arches for thepurpose of providing prostheticsupport for dental restorations(Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is usedto restore a patient's chewingfunction in the followingsituations and with the clinicalprotocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved andwith appropriate occlusalloading. Larger implants arededicated for the molar region. | The ExFeel Dental ImplantSystems are intended to beplaced in the upper or lower jawto support prosthetic devices,such as artificial teeth, and torestore a patient's chewingfunction. This may beaccomplished using either a twostage surgical procedure or asingle stage surgical procedure. |
| Design | Image: Design of subject device | Image: Design of primary predicate device | Image: Design of reference device |
| Diameter (Ø) | 5.5 mm | 3.2, 4.2, 5.2, 6.2 mm | 5.5 mm |
| Total Length | 6.5, 7.5, 8.5 mm | 8.6, 9.6, 10.6, 11.6, 12.6, 13.6,14.6, 15.6 mm | 6.5, 7.5, 8.5 mm |
| Gingival (Cuff)Height | 2.0, 3.0, 4.0 mm | 2.5, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5,9.5 mm | 2.0, 3.0, 4.0 mm |
| Angulation | Straight | Straight | Straight |
| ConnectionInterface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection |
| Material | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) | CP Ti Grade 3(ASTM F67-13) |
| SurfaceTreatment | Machined | Anodizing | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Principle ofOperation | The Healing Abutment isfastened into the female screwof dental implant and supportthe gingival shaping. | The Healing Abutment isfastened into the female screwof dental implant and supportthe gingival shaping. | The Healing Abutment isfastened into the female screwof dental implant and supportthe gingival shaping. |
| Substantial Equivalence Discussion | |||
| 1.Similarities | |||
| Subject Device | Primary Predicate Device | Reference Device | |
| 510(k) No. | K210161 | K182448 | K052369 |
| Device Name(CompatibleImplantSystem) | Multi PostFor AnyOne Onestage ImplantSystem | EZ Post AbutmentFor AnyRidge Octa 1 Implant System | ExFeel Internal Multi-mountFor ExFeel Dental Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | The AnyOne Onestage ImplantSystem is intended to be surgicallyplaced in the maxillary or mandibulararches for the purpose of providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing functionin the following situations and withthe clinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved and withappropriate occlusal loading. Largerimplants are dedicated for the molarregion. | The AnyRidge Octa 1 Implant Systemis intended to be surgically placed inthe maxillary or mandibular archesfor the purpose of providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing functionin the following situations and withthe clinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved and withappropriate occlusal loading. Largerimplants are dedicated for the molarregion. | The ExFeel Dental Implant Systemsare intended to be placed in theupper or lower jaw to supportprosthetic devices, such as artificialteeth, and to restore a patient'schewing function. This may beaccomplished using either a twostage surgical procedure or a singlestage surgical procedure. |
| Design | |||
| Diameter (Ø) | 5.5 mm | 4.0, 5.0, 6.0, 7.0 mm | 5.5 mm |
| Total Length | 8.7 mm | 7.85 - 16.35 mm | 8.7 mm |
| Gingival (Cuff)Height | 1.0 mm | 0.8, 1.8, 2.8, 3.8, 4.8 mm | 1.0 mm |
| Post Height | 5.5 mm | 4.0, 5.5, 7.0 mm | 5.5 mm |
| Angulation | Straight | Straight | Straight |
| ConnectionInterface | Internal Octa | Internal Octa, Internal Non-Octa | Internal Octa |
| Material | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) | CP Ti Grade 3(ASTM F67-13) |
| SurfaceTreatment | Anodizing | Anodizing | Anodizing |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle ofOperation | The Multi Post is asuperstructure which isconnected to the Fixtures usingthe Multi Post Screw. It replacesthe functions of the missingteeth as a dental abutment. | The EZ Post Abutment is asuperstructure which isconnected to the Fixtures usingthe Abutment Screw. It replacesthe functions of the missingteeth as a dental abutment. | The ExFeel Internal Multi-mountis a superstructure which isconnected to the Fixtures usingthe ExFeel Internal Screw. Itreplaces the functions of themissing teeth as a dentalabutment. |
| Substantial Equivalence Discussion | |||
| 1. SimilaritiesThe subject device has the same characteristic for the followings compared to the reference device.Indication for use, Design, Diameter, Total Length, Gingival Height, Post Height, Angulation, Connection Interface,Surface Treatment, Single Use, Sterilization and Principle of Operation | |||
| 2. DifferencesThe subject device has the different characteristic for the followings compared to the reference device.MaterialThe subject device is made of titanium alloy while the reference device is made entirely of commercially puretitanium, but has made with same material with predicate device. Also, the multiple predicate & reference devicesfor titanium alloy are presented in the other component comparison charts. | |||
| 3. DiscussionThe proposed Multi Post had been FDA cleared under K052639 with product name of 'ExFeel Internal Multi-mount' but it is being submitted to change their identifier with modification of product name and material. | |||
| Subject Device | Reference Device | ||
| 510(k) No. | K210161 | K052369 | |
| Device Name(CompatibleImplant System) | Multi Post CapFor AnyOne Onestage Implant System | ExFeel Internal Multi-mount CapFor ExFeel Dental Implant System | |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | |
| Indications forUse Statement | The AnyOne Onestage Implant System is intendedto be surgically placed in the maxillary ormandibular arches for the purpose of providingprosthetic support for dental restorations (Crown,bridges, and overdentures) in partially or fullyedentulous individuals. It is used to restore apatient's chewing function in the followingsituations and with the clinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved and with appropriateocclusal loading. Larger implants are dedicated forthe molar region. | The ExFeel Dental Implant Systems are intended to beplaced in the upper or lower jaw to support prostheticdevices, such as artificial teeth, and to restore a patient'schewing function. This may be accomplished using eithera two stage surgical procedure or a single stage surgicalprocedure. | |
| Design | Image: Design of Multi Post Cap | Image: Design of ExFeel Internal Multi-mount Cap | |
| Diameter (Ø) | 5.9 mm | 5.9 mm | |
| Total Length | 6.5 mm | 6.5 mm | |
| Post Height | 5.5 mm | 5.5 mm | |
| Material | POM | POM | |
| SurfaceTreatment | N/A | N/A | |
| Single Use | Yes | Yes | |
| Sterilization | Non-sterile | Non-sterile | |
| Principle ofOperation | The multi post cap is used to relieve feeling ofirritation and protect until the prosthesis isproduced after the impression is taken. | The multi post cap is used to relieve feeling ofirritation and protect until the prosthesis isproduced after the impression is taken. | |
| Substantial Equivalence Discussion |
ice has the same characteristic for the followings compared to the reference de sublect dei
Indication for use, Design, Diameter, Total Length, Gingival Height, Angulation, Connection Interface, Surface Treatment, Single Use, Sterilization and Principle of Operation
2. Differences
The subject device has the different characteristic for the followings compared to the reference device.
Material -
The subject device is made of titanium alloy while the reference device is made entirely of commercially pure titanium, but has made with same material with predicate device. Also, the multiple predicate & reference devices for titanium alloy are presented in the other component comparison charts.
- Discussion
The proposed Healing Abutment had been FDA cleared with K052639, but it is being submitted to change their identifier with modification of material. Therefore, the proposed Healing Abutment and reference device have common in all the items in the comparison chart except the material difference is explained not affecting on the substantial equivalence. Also, these devices were not tested for fatigue strength as they are not placed into occlusion. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device.
{15}------------------------------------------------
Multi Post
Therefore, the proposed Multi Post and reference device have common in all the items in the comparison chart except the material. The material difference is explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is a straight type. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device.
{16}------------------------------------------------
Multi Post Cap
Similarities T.
The subject device has the same characteristic for the followings compared to the reference device.
Indication for use, Design, Diameter, Total Length, Post Height, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation.
Differences 2.
- N/A
3. Discussion
The proposed Multi Post Cap had been FDA cleared under K052639 with product name of 'ExFeel Internal Multi-mount Cap', but it is being submitted to change their identifier with modification of product name only. Therefore, the proposed Multi Post Cap and reference device have common in all the items in the comparison chart. Also, these devices were not tested for fatigue strength as they are not placed into occlusion. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference device.
{17}------------------------------------------------
EZ Post Abutment
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K210161 | K182448 | K052369 |
| Device Name(CompatibleImplant System) | EZ Post AbutmentFor AnyOne Onestage ImplantSystem | EZ Post AbutmentFor AnyRidge Octa 1 ImplantSystem | Solid AbutmentFor ExFeel Dental Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | The AnyOne Onestage ImplantSystem is intended to besurgically placed in the maxillaryor mandibular arches for thepurpose of providing prostheticsupport for dental restorations(Crown, bridges, andoverdentures) in partially orfully edentulous individuals. It isused to restore a patient'schewing function in thefollowing situations and withthe clinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved andwith appropriate occlusalloading. Larger implants arededicated for the molar region. | The AnyRidge Octa 1 ImplantSystem is intended to besurgically placed in the maxillaryor mandibular arches for thepurpose of providing prostheticsupport for dental restorations(Crown, bridges, andoverdentures) in partially orfully edentulous individuals. It isused to restore a patient'schewing function in thefollowing situations and withthe clinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved andwith appropriate occlusalloading. Larger implants arededicated for the molar region. | The ExFeel Dental Implant Systemsare intended to be placed in theupper or lower jaw to supportprosthetic devices, such as artificialteeth, and to restore a patient'schewing function. This may beaccomplished using either a twostage surgical procedure or a singlestage surgical procedure. |
| Design | Image: Design of EZ Post Abutment | Image: Design of EZ Post Abutment | Image: Design of Solid Abutment |
| Diameter (Ø) | 4.8 mm | 4.0, 5.0, 6.0, 7.0 mm | 3.5 mm |
| Total Length | 6.2, 7.2, 7.7, 8.2, 8.7, 9.2, 9.7,10.2, 10.7, 11.2, 12.2 mm | 7.85, 8.85, 9.35, 9.85, 10.35,10.85, 11.35, 11.85, 12.35,12.85, 13.35, 13.85, 14.35,14.85, 15.35, 16.35 mm | 9.0, 10.5, 12.0 mm |
| Gingival (Cuff)Height | 0.0, 1.0, 2.0, 3.0 mm | 1.0, 2.0, 3.0, 4.0, 5.0 mm | 0.0 mm |
| Post Height | 4.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm |
| Angulation | Straight | Straight | Straight |
| ConnectionInterface | Internal Octa, Internal Non-Octa | Internal Octa, Internal Non-Octa | Internal Conical Connection |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | CP Ti Grade 3 (ASTM F67-13) |
| SurfaceTreatment | Anodizing | Anodizing | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle ofOperation | The EZ Post Abutment is asuperstructure which isconnected to the Fixtures usingthe Multi Post Screw. It replacesthe functions of the missingteeth as a dental abutment. | The EZ Post Abutment is asuperstructure which isconnected to the Fixtures usingthe Abutment Screw. It replacesthe functions of the missingteeth as a dental abutment. | The Solid Abutment is a pre-manufactured prostheticcomponent connected to theendosseous dental implant byits threaded part for aid inprosthetic rehabilitation. |
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the predicate device.
Indication for use, Design, Post Height, Angulation, Connection Interface, Material, Surface Treatment, Single Use, -Sterilization and Principle of Operation
2. Differences
The subject device has the different characteristic for the followings compared to the predicate device.
Diameter -
The diameter of subject device is slightly different with predicate device, but the Diameters of subject device lie within the range of predicate device.
-Total Length
The Length of subject device is slightly different with predicate device, but has same Gingival Height with predicate & reference devices. Also, it does not cause a matter in substantial equivalence since the size difference is very minor.
{18}------------------------------------------------
Gingival (Cuff) Height
The subject device includes the models do not have the cuff height (0.0mm) while the predicate device has cuff height from 1.0 mm to 5.0mm. However, the reference device is not applicable the cuff height as the subject device. The difference in cuff height is acceptable for the subject device as it is intended to be used with a tissue level implant, with a portion of the cuff height built into the implant, whereas the predicate device is intended to be used with a bone level implant which requires a cuff height for all abutments.
3. Discussion -
The proposed EZ Post Abutment is being submitted to add in Megagen's existing prosthetic portfolio which had been FDA cleared. Therefore, the proposed EZ Post Abutment and predicate device have common in all the items in the comparison chart except the Diameter and Total Length. The size differences are explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is straight type. On the basis of the discussion above, it is concluded that the substantially equivalent to the predicate device.
{19}------------------------------------------------
Angled Abutment
| Subject Device | Primary Predicate Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|---|
| 510(k) No. | K210161 | K182448 | K150537 | K182448 |
| Device Name(CompatibleImplantSystem) | Angled AbutmentFor AnyOne OnestageImplant System | Angled AbutmentFor AnyRidge Octa 1Implant System | Angled AbutmentFor MiNi Internal ImplantSystem | Multi-unit AngledAbutmentFor AnyRidge Octa 1Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indicationsfor UseStatement | The AnyOne OnestageImplant System is intendedto be surgically placed inthe maxillary or mandibulararches for the purpose ofproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function in thefollowing situations andwith the clinical protocols:-Delayed loading.-Immediate loading whengoodprimary stability isachieved and withappropriate occlusalloading. Larger implantsare dedicated for the molarregion. | The AnyRidge Octa 1Implant System is intendedto be surgically placed inthe maxillary or mandibulararches for the purpose ofproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function in thefollowing situations andwith the clinical protocols:-Delayed loading.-Immediate loading whengoodprimary stability isachieved and withappropriate occlusalloading. Larger implantsare dedicated for the molarregion. | The MiNi Internal ImplantSystem is intended for two-stage surgical proceduresin the following situationsand with the followingclinical protocols:- The intended use for the3.0 mm diameter MiNiimplant is limited to thereplacement ofmaxillary lateral incisorsand mandibular incisors.- Immediate placement inextraction sites and insituations with a partiallyor completelyhealed alveolar ridge.- It is intended for delayedloading. | The AnyRidge Octa 1Implant System is intendedto be surgically placed inthe maxillary or mandibulararches for the purpose ofproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function in thefollowing situations andwith the clinical protocols:-Delayed loading.-Immediate loading whengoodprimary stability is achievedand with appropriateocclusal loading. Largerimplants are dedicated forthe molar region. |
| Design | ||||
| Diameter (Ø) | 3.7 mm | 4.0, 5.0, 6.0, 7.0mm | 3.5 mm | 4.8 mm |
| Total Length | 9.0 mm | 10.85, 11.85, 12.35,12.85, 13.35, 13.85,14.35, 14.85, 15.35,16.35 mm | 11.7, 12.7, 13.7 mm | 6.8, 7.48, 7.8, 8.48, 8.5,8.8, 8.98, 9.5, 9.98, 10.5mm |
| Gingival(Cuff) Height | N/A | 0.8, 1.8, 2.8, 3.8, 4.8mm | 2.5, 3.5, 4.5 mm | 2.3, 3.3, 4.3mm |
| Post Height | 6.5 mm | 7.0 mm | 7.0 mm | 2.2 mm |
| Angulation | 15°, 25° | 15°, 25° | 15° | 17°, 30° |
| ConnectionInterface | Internal Octa | Internal Octa | Internal Hex | Internal Octa,Internal Non-Octa |
| Material | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) |
| SurfaceTreatment | Anodizing | Anodizing, Machined | Anodizing | Anodizing |
| Single Use | Yes | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Principle ofOperation | The Angled Abutment isa superstructure whichis connected to thefixtures using theAbutment Screw. Itreplaces the functionsof the missing teeth as adental abutment. | The Angled Abutment isa superstructure whichis connected to thefixtures using theAbutment Screw. Itreplaces the functionsof the missing teeth as adental abutment. | The Angled Abutment isa superstructure whichis connected to thefixtures using theAbutment Screw. Itreplaces the functionsof the missing teeth as adental abutment. | The Multi-unit AngledAbutment is a pre-manufacturedprosthetic componentconnected to theendosseous dentalimplant using the Multi-unit Abutment screw foraid in prostheticrehabilitation. |
- Similarities
The subject device has the same characteristic for the followings compared to the predicate device.
Indication for use, Design, Angulation, Connection Interface, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation
{20}------------------------------------------------
| 2. | Differences |
|---|---|
| The subject device has the different characteristic for the followings compared to the predicate device. | |
| - Diameter & Total Length | |
| The diameter and total length of subject device is slightly different with predicate device, but all the dimensions of | |
| subject device lie within combined range of predicate & reference devices. | |
| - Gingival (Cuff) Height & Post Height | |
| The subject device is not applicable the cuff height while the predicate device has the cuff height. That's why the | |
| total length of subject device is slightly shorter than predicate device. However, it can be replaced with Fixture's | |
| cuff height connecting the proposed fixture and angled abutment. | |
| The Post Height of subject device is slightly different with predicate device, but it lies within combined range of | |
| predicate & reference devices. | |
| The difference in cuff height is acceptable for the subject device as it is intended to be used with a tissue level | |
| implant, with a portion of the cuff height built into the implant, whereas the predicate device is intended to be used | |
| 3. | with a bone level implant which requires a cuff height for all abutments.Discussion |
| - The proposed Angled Abutment is being submitted to add in Megagen's existing prosthetic portfolio which had | |
| been FDA cleared as with predicate device. Therefore, the proposed Angled Abutment and predicate device have | |
| common in all the items in the comparison chart except the Diameter, Total Length, Gingival (Cuff) Height and Post | |
| Height. These size differences are explained not affecting on the substantial equivalence, but the fatigue test was | |
| performed on the subject & predicate devices to confirm the substantial equivalence. The subject device, Angled | |
| Abutment has been selected as the representative specimen in this submission under the consideration of worst | |
| case in accordance with 'ISO 14801' and 'Class II Special Controls Guidance Document: Root-form Endosseous | |
| Dental Implants and Endosseous Dental Implant Abutment'. The test result supports that the subject device is | |
| substantially equivalent to the predicate device and the differences are not affecting the substantial equivalence. | |
| On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the | |
| predicate device. | |
{21}------------------------------------------------
Gold Abutment
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) No. | K210161 | K123988 | K123988 |
| Device Name(CompatibleImplant System) | Gold AbutmentFor AnyOne Onestage ImplantSystem | Gold AbutmentFor AnyOne Internal ImplantSystem | Gold CylinderFor AnyOne Internal ImplantSystem |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for UseStatement | The AnyOne Onestage ImplantSystem is intended to be surgicallyplaced in the maxillary ormandibular arches for the purposeof providing prosthetic support fordental restorations (Crown, bridges,and overdentures) in partially orfully edentulous individuals. It isused to restore a patient's chewingfunction in the following situationsand with the clinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved andwith appropriate occlusal loading.Larger implants are dedicated forthe molar region. | The AnyOne Internal ImplantSystem is intended to be surgicallyplaced in the maxillary ormandibular molar areas for thepurpose providing prostheticsupport for dental restorations(Crown, bridges, and overdentures)in partially or fully edentulousindividuals. It is used to restore apatient's chewing function. Smallerimplants (less than 6.0 mm) arededicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implantsare dedicated for the molar regionand are indicated for delayedloading. | The AnyOne Internal ImplantSystem is intended to be surgicallyplaced in the maxillary ormandibular molar areas for thepurpose providing prostheticsupport for dental restorations(Crown, bridges, and overdentures)in partially or fully edentulousindividuals. It is used to restore apatient's chewing function. Smallerimplants (less than 6.0 mm) arededicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implantsare dedicated for the molar regionand are indicated for delayedloading. |
| Design | Image: Red dental implant | Image: Red dental implant | Image: Red dental implant |
| Diameter (Ø) | 5.5 mm | 4.5 mm | 4.0, 4.8, 5.1, 6.0 mm |
| Total Length | 13.65 mm | 15.7 mm | 12.0, 13.0 mm |
| Gingival (Cuff)Height | 1.5 mm | 1.0 mm | 2.0, 3.0 mm |
| Post Height | 10.0 mm | 11.0 mm | 10.0 mm |
| Angulation | Straight | Straight | Straight |
| ConnectionInterface | Internal Octa, Non-Octa | Internal Hex, Non-Hex | Internal Octa, Non-OctaInternal Hex, Non-Hex |
| Material | Body: Gold Alloy / Sleeve: POM | Body: Gold Alloy / Sleeve: POM | Body: Gold Alloy / Sleeve: POM |
| Surface Treatment | N/A | N/A | N/A |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle ofOperation | The Gold Abutment is used inconjunction with fixture to providesupport for screw or cement typefinal prosthesis by casting with goldalloy. It is connected to the Fixturewith Multi Post Screw. | The Gold Abutment is used inconjunction with Fixture to providesupport for screw type finalprosthesis by casting with goldalloy. It is connected to the Fixtureusing the Screw. | The Gold Cylinder is used inconjunction with Octa Abutmentand Multi-unit Abutment to providesupport for screw type finalprosthesis by casting with goldalloy. It is connected to theAbutment using the Screw. |
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the reference devices.
Indication for use, Design, Angulation, Material, Single Use, Sterilization and Principle of Operation
2. Differences
The subject device has the different characteristic for the followings compared to the reference devices.
Diameter, Total Length, Gingival (Cuff) Height and Post Height
- The dimension of subject device is slightly different with reference device 1 but the dimension of subject device lies within combined range of reference device 1 & 2. Also, it does not cause a matter in substantial equivalence since the size difference is very minor. -
- Connection Interface
The subject device has Internal Octa connection while the reference device 1 has Internal Hex connection, but has same connection structure as reference device 2. Also, both feature of Octa and Hex provides anti-rotational feature and multiple predicate & reference devices for Octa / Non-Octa are already presented in the other component comparison charts.
3. Discussion
- । The proposed Gold Abutment is being submitted to add in Megagen's existing prosthetic portfolio which had been FDA cleared. Therefore, the proposed Gold Abutment and reference devices have common in all the items in the comparison chart except the Diameter, Total Length, Gingival (Cuff) Height. These size differences are explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is straight type. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference devices.
{22}------------------------------------------------
CCM Abutment
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K210161 | K182448 | K123988 |
| Device Name(CompatibleImplant System) | CCM AbutmentFor AnyOne Onestage ImplantSystem | CCM AbutmentFor AnyRidge Octa 1 ImplantSystem | CCM CylinderFor AnyOne Internal ImplantSystem |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for UseStatement | The AnyOne Onestage Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:-Delayed loading-Immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region. | The AnyRidge Octa 1 Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:-Delayed loading-Immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region. | The AnyOne Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading. |
| Design | Image | Image | Image |
| Diameter (Ø) | 5.5 mm | 3.8 mm | 4.0, 5.1, 6.0 mm |
| Total Length | 13.65 mm | 14.65 mm | 12.0 mm |
| Gingival (Cuff)Height | 1.5 mm | 1.0 mm | 2.0 mm |
| Post Height | 10.0 mm | 11.6 mm | 10.0 mm |
| Angulation | Straight | Straight | Straight |
| ConnectionInterface | Internal Octa,Internal Non-Octa | Internal Octa,Internal Non-Octa | Internal Octa, Non-Octa |
| Material | Body: Co-Cr-Mo alloySleeve: POM | Body: Co-Cr-Mo AlloySleeve: POM | Body: Co-Cr-Mo AlloySleeve: POM |
| Surface Treatment | N/A | N/A | N/A |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle ofOperation | The CCM Abutment is used in conjunction with fixture to provide support for screw or cement type final prosthesis by casting with CCM alloy. It is connected to the Fixture with Multi Post Screw. | The CCM Abutment is used in conjunction with Fixture to provide support for screw type final prosthesis by casting with CCM alloy. It is connected to the Fixture using the Screw. | The CCM Cylinder is used in conjunction with Octa Abutment to provide support for screw type final prosthesis by casting with CCM alloy. It is connected to the Abutment using the Screw. |
| Substantial Equivalence Discussion | |||
| 1.SimilaritiesThe subject device has the same characteristic for the followings compared to the predicate device. |
- Indication for use, Design, Angulation, Connection Interface, Material, Single Use, Sterilizati Operation
2. Differences
- The subject device has the different characteristic for the followings compared to the predicate device.
- Diameter, Total Length, Gingival (Cuff) Height and Post Height -The dimension of subject device is slightly different with predicate device but the dimension of subject device lies within combined range of predicate & reference devices. Also, it does not cause a matter in substantial equivalence since the size difference is very minor.
- Discussion
- The proposed CCM Abutment is being submitted to add in Megagen's existing prosthetic portfolio which had been -FDA cleared. Therefore, the proposed CCM Abutment and predicate device have common in all the items in the comparison chart except the Diameter, Total Length, Gingival (Cuff) Height and Post Height. These size differences are explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is straight type. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device.
{23}------------------------------------------------
Multi Post Screw
| Subject Device | Reference Device | |
|---|---|---|
| 510(k) No. | K210161 | K052369 |
| Device Name(CompatibleImplant System) | Multi Post ScrewFor AnyOne Onestage Implant System | ExFeel Internal ScrewFor ExFeel Dental Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | The AnyOne Onestage Implant System is intendedto be surgically placed in the maxillary ormandibular arches for the purpose of providingprosthetic support for dental restorations (Crown,bridges, and overdentures) in partially or fullyedentulous individuals. It is used to restore apatient's chewing function in the followingsituations and with the clinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved and with appropriateocclusal loading. Larger implants are dedicated forthe molar region. | The ExFeel Dental Implant Systems are intended to beplaced in the upper or lower jaw to support prostheticdevices, such as artificial teeth, and to restore a patient'schewing function. This may be accomplished using eithera two stage surgical procedure or a single stage surgicalprocedure. |
| Design | ||
| Diameter (Ø) | 2.5 mm | 2.5 mm |
| Total Length | 8.1 mm | 8.1 mm |
| ConnectionInterface | Internal Conical Connection | Internal Conical Connection |
| Material | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) |
| SurfaceTreatment | Machined | Machined |
| Single Use | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile |
| Principle ofOperation | The Multi Post Screw is used for connecting theMulti Post, EZ Post Abutment, Gold Abutment andCCM Abutment to the Fixture. | The ExFeel Internal Screw is used for connectingthe ExFeel Internal Multi-mount, EZ PostAbutment, Gold Abutment and CCM Abutment tothe Fixture. |
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the reference device.
- Indication for use, Design, Diameter, Total Length, Connection Interface, Material, Surface Treatment, Single Use, -Sterilization and Principle of Operation.
Differences 2. N/A
3. Discussion
The proposed Multi Post Screw had been FDA cleared under K052639 with product name of 'ExFeel Internal Screw', but it is being submitted to change their identifier with modification of product name only. Therefore, the subject device and reference device have common in all the items in the comparison chart.
On the basis of the discussion above, it is concluded that the substantially equivalent to the reference device.
{24}------------------------------------------------
Solid Abutment
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K210161 | K182448 | K052369 |
| Device Name(CompatibleImplantSystem) | Solid AbutmentFor AnyOne Onestage ImplantSystem | EZ Post AbutmentFor AnyRidge Octa 1 Implant System | Solid AbutmentFor ExFeel Dental Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | The AnyOne Onestage ImplantSystem is intended to besurgically placed in the maxillaryor mandibular arches for thepurpose of providing prostheticsupport for dental restorations(Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is usedto restore a patient's chewingfunction in the followingsituations and with the clinicalprotocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved andwith appropriate occlusalloading. Larger implants arededicated for the molar region. | The AnyRidge Octa 1 ImplantSystem is intended to besurgically placed in the maxillaryor mandibular arches for thepurpose of providing prostheticsupport for dental restorations(Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is usedto restore a patient's chewingfunction in the followingsituations and with the clinicalprotocols:-Delayed loading-Immediate loading when goodprimary stability is achieved andwith appropriate occlusalloading. Larger implants arededicated for the molar region. | The ExFeel Dental Implant Systemsare intended to be placed in theupper or lower jaw to supportprosthetic devices, such as artificialteeth, and to restore a patient'schewing function. This may beaccomplished using either a twostage surgical procedure or a singlestage surgical procedure. |
| Design | |||
| Diameter (Ø) | 3.5 mm | 4.0, 5.0, 6.0, 7.0 mm | 3.5 mm |
| Total Length | 9.0, 10.5, 12.0 mm | 7.85 - 16.35 mm | 9.0, 10.5, 12.0 mm |
| Post Height | 4.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm |
| Angulation | Straight | Straight | Straight |
| ConnectionInterface | Internal Conical Connection | Internal Octa, Internal Non-Octa | Internal Conical Connection |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | CP Ti Grade 3 (ASTM F67-13) |
| SurfaceTreatment | Machined | Anodizing | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle ofOperation | The Solid Abutment is a pre-manufactured prostheticcomponent connected to theendosseous dental implant by itsthreaded part for aid inprosthetic rehabilitation. | The EZ Post Abutment is asuperstructure which isconnected to the Fixtures usingthe Abutment Screw. It replacesthe functions of the missing teethas a dental abutment. | The Solid Abutment is a pre-manufactured prostheticcomponent connected to theendosseous dental implant byits threaded part for aid inprosthetic rehabilitation. |
| Substantial Equivalence Discussion | |||
| 1. Similarities | |||
| The subject device has the same characteristic for the followings compared to the reference device. | |||
| Indication for use, Design, Diameter, Total Length, Post Height, Angulation, Connection Interface, Surface | |||
| Treatment, Single Use, Sterilization and Principle of Operation | |||
| 2. Differences | |||
| The subject device has the different characteristic for the followings compared to the reference device. | |||
| Material | |||
| The subject device is made of titanium alloy while the reference device is made entirely of commercially pure | |||
| titanium, but has made with same material with predicate device. Also, the multiple predicate & reference devices | |||
| for titanium alloy are presented in the other component comparison charts. | |||
| 3. Discussion | |||
| The proposed Solid Abutment had been FDA cleared under K052639, but it is being submitted to change their | |||
| identifier with modification of material only. Therefore, the proposed Solid Abutment and reference device have | |||
| common in all the items in the comparison chart except the material. The material difference is explained not | |||
| affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is a | |||
| straight type. On the basis of the discussion above, it is concluded that the subject device is substantially | |||
| equivalent to the predicate device. |
{25}------------------------------------------------
Solid Cap
| Subject Device | Reference Device | |
|---|---|---|
| 510(k) No. | K210161 | K052369 |
| Device Name(CompatibleImplant System) | Solid CapFor AnyOne Onestage Implant System | Solid Protect CapFor ExFeel Dental Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | The AnyOne Onestage Implant System is intendedto be surgically placed in the maxillary ormandibular arches for the purpose of providingprosthetic support for dental restorations (Crown,bridges, and overdentures) in partially or fullyedentulous individuals. It is used to restore apatient's chewing function in the followingsituations and with the clinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved and with appropriateocclusal loading. Larger implants are dedicated forthe molar region. | The ExFeel Dental Implant Systems are intended to beplaced in the upper or lower jaw to support prostheticdevices, such as artificial teeth, and to restore a patient'schewing function. This may be accomplished using eithera two stage surgical procedure or a single stage surgicalprocedure. |
| Design | Image: U shape | Image: U shape |
| Diameter (Ø) | 5.7 mm | 5.7 mm |
| Total Length | 6.5, 8.0, 9.5 mm | 6.5, 8.0, 9.5 mm |
| Post Height | 4.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm |
| Material | POM | POM |
| Single Use | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile |
| Principle ofOperation | The Solid Cap is used for protecting a SolidAbutment after taking impression, and minimizingirritation to tongue and oral mucosa. | The Solid Protect Cap is used for protecting a SolidAbutment after taking impression, and minimizingirritation to tongue and oral mucosa. |
| Substantial Equivalence Discussion | ||
| 1. SimilaritiesThe subject device has the same characteristic for the followings compared to the reference device.Indication for use, Design, Diameter, Total Length, Post Height, Material, Single Use, Sterilization and Principle ofOperation.2. DifferencesN/A3. DiscussionThe proposed Solid Cap had been FDA cleared under K052639 with product name of 'Solid Protect Cap', but it is |
being submitted to change their identifier with modification of product name only. Therefore, the subject device and reference device have common in all the items in the comparison chart. Also, these devices were not tested for fatigue strength as they are not placed into occlusion. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference device.
{26}------------------------------------------------
Solid Post Abutment
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) No. | K210161 | K123988 | K160670 |
| Device Name(CompatibleImplant System) | Solid Post AbutmentFor AnyOne Onestage ImplantSystem | Solid AbutmentFor AnyOne Internal Implant System | Solid AbutmentFor ET US SS Prosthetic System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Indications forUse Statement | The AnyOne Onestage ImplantSystem is intended to be surgicallyplaced in the maxillary or mandibulararches for the purpose of providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing functionin the following situations and withthe clinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved and withappropriate occlusal loading. Largerimplants are dedicated for the molarregion.. | The AnyOne Internal Implant Systemis intended to be surgically placed inthe maxillary or mandibular molarareas for the purpose providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.Smaller implants (less than 6.0 mm)are dedicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implants arededicated for the molar region andare indicated for delayed loading. | ET SystemThe HIOSSEN Prosthetic system isintended for use with a dentalimplant to provide support forprosthetic restorations such ascrowns, bridges, or over-dentures.US/SS SystemThe OSSTEM Prosthetic system isintended for use with a dentalimplant to provide support forprosthetic restorations such ascrowns, bridges, or over-dentures. |
| Design | Image: design | Image: design | Image: design |
| Diameter (Ø) | 4.9 mm | 4.0, 4.5, 5.5, 6.5 mm | 3.5, 4.3 mm |
| Total Length | 9.5, 10.5, 11.0, 11.5, 12.0, 12.5,13.0, 13.5, 14.5 mm | 11.2, 12.1 12.7, 13.2, 13.7, 14.2,14.7, 15.2, 15.7, 16.2, 16.7,17.2, 17.7, 18.7 mm | 9.5, 9.8, 11, 11.3, 12.5, 12.8 mm |
| Gingival (Cuff)Height | 1.0, 2.0, 3.0 mm | 1.0, 1.5 2.5, 3.5, 4.5, 5.5mm | Not known |
| Post Height | 4.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0mm | Not known |
| Angulation | Straight | Straight | Straight |
| ConnectionInterface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | Titanium Alloy |
| SurfaceTreatment | Machined | Machined | Not known |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle ofOperation | The Solid Post Abutment is a pre-manufactured prostheticcomponent connected to theendosseous dental implant by itsthreaded part for aid inprosthetic rehabilitation. | The Solid Abutment is a pre-manufactured prostheticcomponent connected to theendosseous dental implant by itsthreaded part for aid inprosthetic rehabilitation. | The Solid Abutment is a pre-manufactured prostheticcomponent connected to theendosseous dental implant by itsthreaded part for aid inprosthetic rehabilitation. |
1. Similarities
The subject device has the same characteristic for the followings compared to the reference devices.
- Indication for use, Design, Post Height, Angulation, Connection Interface, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation
Differences 2.
The subject device has the different characteristic for the followings compared to the reference devices.
- Diameter & Gingival (Cuff) Heights -
- The diameter and Gingival (Cuff) Height of subject device is slightly different with reference devices, but these dimensions lie within the range of reference device 1.
-Total Length
The Total Length of subject device is slightly different with reference devices, but it lies within combined range of reference device 1&2, and has similar Gingival Height with reference device 1. Also, it does not cause a matter in substantial equivalence since the size difference is very minor, and the variety of the size can be possible to operate more precise treatment to meet each patient's condition.
3. Discussion
- The proposed Solid Post Abutment and reference devices have common in all the items in the comparison chart " except the Diameter, Total Length and Gingival (Cuff) Height. These size differences are explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is straight type. On the basis of the discussion above, it is concluded that the substantially equivalent to the reference devices.
{27}------------------------------------------------
Solid Post Cap
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) No. | K210161 | K052369 | K123988 |
| Device Name(CompatibleImplant System) | Solid Post CapFor AnyOne Onestage ImplantSystem | Solid Protect CapFor ExFeel Dental Implant System | Comfort CapFor AnyOne Internal Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | The AnyOne Onestage ImplantSystem is intended to besurgically placed in the maxillaryor mandibular arches for thepurpose of providing prostheticsupport for dental restorations(Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is usedto restore a patient's chewingfunction in the followingsituations and with the clinicalprotocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved andwith appropriate occlusalloading. Larger implants arededicated for the molar region. | The ExFeel Dental Implant Systemsare intended to be placed in theupper or lower jaw to supportprosthetic devices, such as artificialteeth, and to restore a patient'schewing function. This may beaccomplished using either a twostage surgical procedure or a singlestage surgical procedure. | The AnyOne Internal Implant Systemis intended to be surgically placed inthe maxillary or mandibular molarareas for the purpose providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.Smaller implants (less than 6.0 mm)are dedicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implants arededicated for the molar region andare indicated for delayed loading. |
| Design | Image: Subject Device Design | Image: Reference Device 1 Design | Image: Reference Device 2 Design |
| Diameter (Ø) | 5.3 mm | 5.7 mm | 4.0, 4.5, 5.5, 6.5 mm |
| Total Length | 6.5, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0,10.5, 11.5 mm | 6.5, 8.0, 9.5 mm | 5.4, 5.5, 5.6, 6.9, 7.0, 7.1, 8.4,8.5, 8.6 mm |
| Gingival (Cuff)Height | 1.0, 2.0, 3.0 mm | N/A | N/A |
| Post Height | 4.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm |
| Material | POM | POM | POM |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle ofOperation | The Solid Post Cap is used forprotecting a Solid Post Abutmentafter taking impression, andminimizing irritation to tongueand oral mucosa. | The Solid Protect Cap is used forprotecting a Solid Abutmentafter taking impression, andminimizing irritation to tongueand oral mucosa. | The Comfort Cap is used forprotecting a Solid Abutmentafter taking impression, andminimizing irritation to tongueand oral mucosa. |
| Substantial Equivalence Discussion | |||
| 1. Similarities |
The subject device has the same characteristic for the followings compared to the reference devices.
Indication for use, Design, Post Height, Material, Single Use, Sterilization and Principle of Operation.
2. Differences
The subject device has the different characteristic for the followings compared to the reference devices.
- Diameter, Total Length and Gingival (Cuff) Height -The diameter of subject device is slightly different with reference device 1, but it lies within combined range of reference device 1&2. The total length is slightly different with reference device 1, but has same post height with reference device 1&2. And, the subject device has the cuff height corresponding to the its compatible abutment, while the reference devices are not applicable, but these do not cause a matter in substantial equivalence since the size difference is very minor, and the variety of the size can be possible to operate more precise treatment to meet each patient's
condition. 3. Discussion
- The proposed Solid Post Cap and reference devices have common in all the items in the comparison chart except the Diameter, Total Length and Gingival (Cuff) Height. These size differences are explained not affecting on the substantial equivalence. Also, these devices were not tested for fatigue strength as they are not placed into occlusion. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference devices.
{28}------------------------------------------------
Octa Abutment
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K210161 | K182448 | K171027 |
| Device Name(Compatible ImplantSystem) | Octa AbutmentFor AnyOne Onestage ImplantSystem | Octa AbutmentFor AnyRidge Octa 1 ImplantSystem | Octa AbutmentDentis Dental Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Dentis Co., Ltd. |
| Indications for UseStatement | The AnyOne Onestage ImplantSystem is intended to be surgicallyplaced in the maxillaryormandibular arches for the purposeof providing prosthetic support fordental restorations (Crown,bridges, and overdentures) inpartially or fully edentulousindividuals. It is used to restore apatient's chewing function in thefollowing situations and with theclinical protocols:-Delayed loading-Immediate loading when goodprimary stability is achieved andwith appropriate occlusal loading.Larger implants are dedicated forthe molar region. | The AnyRidge Octa 1 ImplantSystem is intended to be surgicallyplaced in the maxillaryormandibular arches for the purposeof providing prosthetic support fordental restorations (Crown,bridges, and overdentures) inpartially or fully edentulousindividuals. It is used to restore apatient's chewing function in thefollowing situations and with theclinical protocols:-Delayed loading-Immediate loading when goodprimary stability is achieved andwith appropriate occlusal loading.Larger implants are dedicated forthe molar region. | The Dentis Dental Implant System isan endosseous dental implant thatis indicated for surgical placementin the upper and lower jaw arches,to provide a root form means forsingle or multiple-units prostheticappliance attachment to restore apatient 's chewing function.Implants can be placed with aconventional two stage surgicalprocess with an option fortransmucosal healing or they canbe placed in a single stage surgicalprocess for immediate loadingwhen good primary stability hasbeen achieved and withappropriate occlusal loading. |
| Design | |||
| Diameter (Ø) | 3.5 mm | 3.8, 4.8, 5.8 mm | 3.5, 4.3 |
| Total Length | 6.5 mm | 7.85, 8.85, 9.35, 9.85, 10.35,10.85, 11.35, 11.85, 12.35,12.85, 13.35, 13.85, 14.85 mm | 7.0,7.3 mm |
| Gingival (Cuff)Height | N/A | 1.0, 2.0, 3.0, 4.0, 5.0 mm | Not known |
| Post Height | 1.5 mm | 1.5 mm | Not known |
| Angulation | Straight | Straight | Straight |
| ConnectionInterface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) |
| Surface Treatment | Machined | Anodizing | Not known |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle ofOperation | The Octa Abutment is a pre-manufactured prostheticcomponent connected to theendosseous dental implant byits threaded part for aid inprosthetic rehabilitation.This device is a two pieceabutment that is always usedwith a cylinder (such as theTemporary Cylinder, EZ PostCylinder, Gold Cylinder, or CCMCylinder) to form the finalabutment. | The Octa Abutment is a pre-manufactured prostheticcomponent connected to theendosseous dental implant byits threaded part for aid inprosthetic rehabilitation.This device is a two pieceabutment that is always usedwith a cylinder (such as theTemporary Cylinder, EZ PostCylinder, Gold Cylinder, or CCMCylinder) to form the finalabutment. | The Octa Abutment is a pre-manufactured prostheticcomponent connected to theendosseous dental implant byits threaded part for aid inprosthetic rehabilitation. |
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the predicate device.
Indication for use, Design, Post Height, Angulation, Connection Interface, Material, Single Use, Sterilization and -Principle of Operation
2. Differences
The subject device has the different characteristic for the followings compared to the predicate device.
Diameter, Total Length and Gingival (Cuff) Height
Blameter of subject device is slightly different with predicate device, but it lies within combined range of predicate & Reference devices. The total length is slightly different with predicate device, but has same post height with predicate devices. The subject device is not applicable the cuff height while the predicate device has the cuff height. That's why the total length of subject device is slightly shorter than predicate device. However, it can be replaced with Fixture's cuff height connecting the proposed fixture and octa abutment. The difference in cuff height is acceptable for the subject device as it is intended to be used with a tissue level implant, with a portion of the cuff height built into the implant, whereas the predicate device is intended to be used with a bone level implant which requires a cuff height for all abutments.
{29}------------------------------------------------
3. Discussion 1
The proposed Octa Abutment is being submitted to add in Megagen's existing prosthetic portfolio which had been FDA cleared. Therefore, the proposed Octa Abutment and predicate device have common in all the items in the comparison chart except the Diameter, Total Length and Gingival (Cuff) Height. These size differences are explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is straight type. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device.
{30}------------------------------------------------
Healing Cap
| Subject Device | Reference Device | |
|---|---|---|
| 510(k) No. | K210161 | K123988 |
| Device Name(CompatibleImplant System) | Healing CapFor AnyOne Onestage Implant System | Octa Healing CapFor AnyOne Internal Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | The AnyOne Onestage Implant System is intendedto be surgically placed in the maxillary ormandibular arches for the purpose of providingprosthetic support for dental restorations (Crown,bridges, and overdentures) in partially or fullyedentulous individuals. It is used to restore apatient's chewing function in the followingsituations and with the clinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved and with appropriateocclusal loading. Larger implants are dedicated forthe molar region. | The AnyOne Internal Implant System is intended to besurgically placed in the maxillary or mandibular molarareas for the purpose providing prosthetic support fordental restorations (Crown, bridges, and overdentures)in partially or fully edentulous individuals. It is used torestore a patient's chewing function. Smaller implants(less than 6.0 mm) are dedicated for immediate loadingwhen good primary stability is achieved and withappropriate occlusal loading. Larger implants arededicated for the molar region and are indicated fordelayed loading. |
| Design | Image: Healing Cap | Image: Octa Healing Cap |
| Diameter (Ø) | 5.2 mm | 5.2 mm |
| Total Length | 4.0 mm | 4.0 mm |
| ConnectionInterface | Two-piece (with titanium alloy screw) | Two-piece (with titanium alloy screw) |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) |
| SurfaceTreatment | Machined | Machined |
| Single Use | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile |
| Principle ofOperation | The Healing Cap is used for protecting OctaAbutment and minimizing irritation to tongue andoral mucosa during period of gingival healing. It isconnected to the Abutment using AbutmentScrew. | The Octa Healing Cap is used for protecting OctaAbutment and minimizing irritation to tongue andoral mucosa during period of gingival healing. It isconnected to the Abutment using AbutmentScrew. |
| Substantial Equivalence Discussion | ||
| 1.Similarities |
The subject device has the same characteristic for the followings compared to the reference device.
Indication for use, Design, Diameter, Total Length, Connection Interface, Material, Surface Treatment, Single Use, -Sterilization and Principle of Operation.
2. Differences
N/A 3. Discussion
The proposed Healing Cap had been FDA cleared under K123988 with product name of 'Octa Healing Cap', but it is being submitted to change their identifier with modification of product name only. Therefore, the subject device and reference device have common in all the items in the comparison chart. Also, these devices were not tested for fatigue strength as they are not placed into occlusion. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference device.
{31}------------------------------------------------
Temporary Cylinder
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K210161 | K182448 | K123988 |
| Device Name(CompatibleImplantSystem) | Temporary CylinderFor AnyOne Onestage ImplantSystem | Temporary AbutmentFor AnyRidge Octa 1 ImplantSystem | Temporary CylinderFor AnyOne Internal Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | The AnyOne Onestage ImplantSystem is intended to besurgically placed in the maxillaryor mandibular arches for thepurpose of providing prostheticsupport for dental restorations(Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is usedto restore a patient's chewingfunction in the followingsituations and with the clinicalprotocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved andwith appropriate occlusalloading. Larger implants arededicated for the molar region. | The AnyRidge Octa 1 Implant Systemis intended to be surgically placed inthe maxillary or mandibular archesfor the purpose of providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing functionin the following situations and withthe clinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved and withappropriate occlusal loading. Largerimplants are dedicated for the molarregion. | The AnyOne Internal Implant Systemis intended to be surgically placed inthe maxillary or mandibular molarareas for the purpose providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.Smaller implants (less than 6.0 mm)are dedicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implants arededicated for the molar region andare indicated for delayed loading. |
| Design | Image: Design of Temporary Cylinder | Image: Design of Temporary Abutment | Image: Design of Temporary Cylinder |
| Diameter (Ø) | 5.0 mm | 4.0, 4.5, 5.0 mm | 5.0 mm |
| Total Length | 10.0 mm | 14.85, 15.85, 16.35, 17.35 mm | 10.0 mm |
| Post Height | 7.0 mm | 10 mm | 7.0 mm |
| Angulation | Straight | Straight | Straight |
| ConnectionInterface | Octa, Non-Octa | Octa, Non-Octa | Octa, Non-Octa |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | CP Ti Grade 4 (ASTM F67-13) |
| SurfaceTreatment | Machined | Machined | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle ofOperation | The Temporary Cylinder is usedin conjunction with OctaAbutment to provide support forprovisional restoration. It isconnected to the Abutmentusing Abutment Screw | The Temporary Abutment is usedin conjunction with Fixture toprovide support for provisionalrestoration. It is connected toFixture using the Screw. | The Temporary Cylinder is usedin conjunction with OctaAbutment to provide support forprovisional restoration. It isconnected to the Abutmentusing the Screw. |
| Substantial Equivalence Discussion | |||
| 1.SimilaritiesThe subject device has the same characteristic for the followings compared to the reference device.Indication for use, Design, Diameter, Total Length, Post Height, Angulation, Connection Interface, Surface | |||
| Subject Device | Primary Predicate Device | Reference Device | |
| 510(k) No. | K210161 | K182448 | K123988 |
| Device Name(CompatibleImplantSystem) | EZ Post CylinderFor AnyOne Onestage ImplantSystem | EZ Post AbutmentFor AnyRidge Octa 1 Implant System | EZ Post CylinderFor AnyOne Internal Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | The AnyOne Onestage ImplantSystem is intended to be surgicallyplaced in the maxillary or mandibulararches for the purpose of providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing functionin the following situations and withthe clinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved and withappropriate occlusal loading. Largerimplants are dedicated for the molarregion. | The AnyRidge Octa 1 ImplantSystem is intended to besurgically placed in the maxillaryor mandibular arches for thepurpose of providing prostheticsupport for dental restorations(Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is usedto restore a patient's chewingfunction in the followingsituations and with the clinicalprotocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved andwith appropriate occlusalloading. Larger implants arededicated for the molar region. | The AnyOne Internal Implant Systemis intended to be surgically placed inthe maxillary or mandibular molarareas for the purpose providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.Smaller implants (less than 6.0 mm)are dedicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implants arededicated for the molar region andare indicated for delayed loading. |
| Design | |||
| Diameter (Ø) | 5.0 mm | 4.0, 5.0, 6.0, 7.0 mm | 5.0 mm |
| Total Length | 5.5, 7.0 mm | 7.85 - 16.35 mm | 5.5, 7.0 mm |
| Post Height | 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm | 5.5, 7.0 mm |
| Angulation | Straight | Straight | Straight |
| ConnectionInterface | Octa, Non-Octa | Octa, Non-Octa | Octa, Non-Octa |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | CP Ti Grade 4 (ASTM F67-13) |
| SurfaceTreatment | Anodizing | Anodizing | Anodizing |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle ofOperation | The EZ Post Cylinder is used inconjunction with Octa Abutmentto provide support for cementand screw type final prosthesis.It is connected to the Abutmentusing Abutment Screw. | The EZ Post Abutment is asuperstructure which isconnected to the Fixtures usingthe Abutment Screw. It replacesthe functions of the missingteeth as a dental abutment. | The EZ Post Cylinder is used inconjunction with Octa Abutmentto provide support for cementand screw type final prosthesis.It is connected to the Abutmentusing Abutment Screw. |
| Substantial Equivalence Discussion | |||
| 1. SimilaritiesThe 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, SurfaceTreatment, Single Use, Sterilization and Principle of Operation | |||
| 2. DifferencesThe subject device has the different characteristic for the followings compared to the reference device.MaterialThe subject device is made of titanium alloy while the reference device is made entirely of commercially puretitanium, but has made with same material with predicate device. Also, the multiple predicate & reference devicesfor titanium alloy are presented in the other component comparison charts. | |||
| 3. DiscussionThe proposed EZ Post Cylinder had been FDA cleared under K123988, but it is being submitted to change their | |||
| identifier with modification of material only. Therefore, the proposed EZ Post Cylinder and reference device havecommon in all the items in the comparison chart except the material. The material difference is explained notaffecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is astraight type. On the basis of the discussion above, it is concluded that the subject device is substantiallyequivalent to the predicate device. | |||
| Subject Device | Reference Device | ||
| 510(k) No. | K210161 | K123988 | |
| Device Name(Compatible ImplantSystem) | Gold CylinderFor AnyOne Onestage Implant System | Gold CylinderFor AnyOne Internal Implant System | |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | |
| Indications for UseStatement | The AnyOne Onestage Implant System isintended to be surgically placed in the maxillaryor mandibular arches for the purpose ofproviding prosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fully edentulousindividuals. It is used to restore a patient'schewing function in the following situationsand with the clinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved and withappropriate occlusal loading. Larger implantsare dedicated for the molar region. | The AnyOne Internal Implant System is intended tobe surgically placed in the maxillary or mandibularmolar areas for the purpose providing prostheticsupport for dental restorations (Crown, bridges, andoverdentures) in partially or fully edentulousindividuals. It is used to restore a patient's chewingfunction. Smaller implants (less than 6.0 mm) arededicated for immediate loading when good primarystability is achieved and with appropriate occlusalloading. Larger implants are dedicated for the molarregion and are indicated for delayed loading. | |
| Design | Image: red cylinder | Image: red cylinder | |
| Diameter (Ø) | 5.1 mm | 5.1 mm | |
| Total Length | 12.0 mm | 12.0 mm | |
| Post Height | 10.0 mm | 10.0 mm | |
| Angulation | Straight | Straight | |
| Connection Interface | Octa, Non-Octa | Octa, Non-Octa | |
| Material | Body: Gold AlloySleeve: POM | Body: Gold AlloySleeve: POM | |
| Surface Treatment | N/A | N/A | |
| Single Use | Yes | Yes | |
| Sterilization | Non-sterile | Non-sterile | |
| Principle of Operation | The Gold Cylinder is used in conjunction withOcta Abutment to provide support for screwtype final prosthesis by casting with Gold alloy.It is connected to the Abutment usingAbutment Screw. | The Gold Cylinder is used in conjunction withOcta Abutment to provide support for screwtype final prosthesis by casting with Gold alloy.It is connected to the Abutment usingAbutment Screw. | |
| Substantial Equivalence Discussion | |||
| 1. SimilaritiesThe 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, SingleUse, Sterilization and Principle of Operation | |||
| 2. DifferencesThe subject device has the different characteristic for the followings compared to the reference device. |
- Treatment, Single Use, Sterilization and Principle of Operation
2. Differences
- The subject device has the different characteristic for the followings compared to the reference device.
- Material -The subject device is made of titanium alloy while the reference device is made entirely of commercially pure titanium, but has made with same material with predicate device. Also, the multiple predicate & reference devices for titanium alloy are presented in the other component comparison charts.
- Discussion
- The proposed Temporary Cylinder had been FDA cleared under K123988, but it is being submitted to change their identifier with modification of material only. Therefore, the proposed Temporary Cylinder and reference device have common in all the items in the comparison chart except the material difference is explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is a straight type. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device.
{32}------------------------------------------------
EZ Post Cylinder
{33}------------------------------------------------
Gold Cylinder
- Discussion
The proposed Gold Cylinder had been FDA cleared under K123988, but it is being submitted to change their identifier only without any modification. Therefore, the proposed Gold Cylinder and reference device have common in all the items in the comparison chart. Also, the fatigue testing is not considered since the proposed device is a straight type. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference device.
{34}------------------------------------------------
CCM Cylinder
| Subject Device | Reference Device | |
|---|---|---|
| 510(k) No. | K210161 | K123988 |
| Device Name(Compatible ImplantSystem) | CCM CylinderFor AnyOne Onestage Implant System | CCM CylinderFor AnyOne Internal Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for UseStatement | The AnyOne Onestage Implant System isintended to be surgically placed in the maxillaryor mandibular arches for the purpose ofproviding prosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fully edentulousindividuals. It is used to restore a patient'schewing function in the following situationsand with the clinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved and withappropriate occlusal loading. Larger implantsare dedicated for the molar region. | The AnyOne Internal Implant System is intended tobe surgically placed in the maxillary or mandibularmolar areas for the purpose providing prostheticsupport for dental restorations (Crown, bridges, andoverdentures) in partially or fully edentulousindividuals. It is used to restore a patient's chewingfunction. Smaller implants (less than 6.0 mm) arededicated for immediate loading when good primarystability is achieved and with appropriate occlusalloading. Larger implants are dedicated for the molarregion and are indicated for delayed loading. |
| Design | Image: [implant design] | Image: [implant design] |
| Diameter (Ø) | 5.1 mm | 5.1 mm |
| Total Length | 12.0 mm | 12.0 mm |
| Post Height | 10.0 mm | 10.0 mm |
| Angulation | Straight | Straight |
| Connection Interface | Octa, Non-Octa | Octa, Non-Octa |
| Material | Body: Co-Cr-Mo alloySleeve: POM | Body: Co-Cr-Mo alloySleeve: POM |
| Surface Treatment | N/A | N/A |
| Single Use | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile |
| Principle of Operation | The CCM Cylinder is used in conjunction withOcta Abutment to provide support for screwtype final prosthesis by casting with CCM alloy.It is connected to the Abutment usingAbutment Screw. | The CCM Cylinder is used in conjunction withOcta Abutment to provide support for screwtype final prosthesis by casting with CCM alloy.It is connected to the Abutment usingAbutment Screw. |
| Substantial Equivalence Discussion | ||
| 1. SimilaritiesThe 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, SingleUse, Sterilization and Principle of Operation | ||
| 2. DifferencesThe subject device has the different characteristic for the followings compared to the reference device.- N/A | ||
| 3. DiscussionThe proposed CCM Cylinder had been FDA cleared under K123988, but it is being submitted to change theiridentifier only without any modification. Therefore, the proposed CCM Cylinder and reference device have common |
in all the items in the comparison chart. Also, the fatigue testing is not considered since is a straight type. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent
to the reference device.
{35}------------------------------------------------
Abutment Screw
| Subject Device | Reference Device 1 | Reference Device 2 | Subject Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | Reference Device 4 | ||
|---|---|---|---|---|---|---|---|---|---|
| 510(k) No. | K210161 | K123988 | K123988 | 510(k) No. | K210161 | K192614 | K150537 | K182091 | K192614 |
| Device Name(CompatibleImplant System) | Abutment ScrewFor AnyOne Onestage ImplantSystem | Octa Abutment ScrewFor AnyOne Internal Implant System | Multi-unit Abutment ScrewFor AnyOne Internal Implant System | Device Name(CompatibleImplantSystem) | Meg-LocAbutmentFor AnyOne OnestageImplant System | Meg-LocAbutmentFor ExFeel DentalImplant System | Meg-RheinAbutmentFor MiNi InternalImplant System | Port AbutmentFor TS SA, SS SA, USSA, MS SA Implant | Meg-MagnetAbutmentForAnyRidge, AnyOne,AnyRidge Octa 1,ExFeel InternalImplant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Osstem Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | The AnyOne Onestage Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:-Delayed loading.-Immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region. | The AnyOne Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading. | The AnyOne Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading. | Indicationsfor UseStatement | The AnyOneOnestage ImplantSystem is intended tobe surgically placedin the maxillary ormandibular archesfor the purpose ofproviding prostheticsupport for dentalrestorations (Crown,bridges, andoverdentures) inpartially or fullyedentulousindividuals. It is usedto restore a patient'schewing function inthe followingsituations and withthe clinical protocols:-Delayed loading.-Immediate loadingwhen goodprimary stability isachieved and withappropriate occlusalloading. Largerimplants arededicated for themolar region. | Meg-Ball AttachmentSystem, Meg-LocAbutment, Meg-Magnet Abutment isintended to be usedin the upper or lowerjaw and used forsupporting toothreplacements torestore chewingfunction. Intendedfor fully edentulousjaw retaining a tissuesupportedoverdenture.The abutments incombination withendosseous implantsare used as thefoundation foranchoring toothreplacements ineither jaw. Theattachments areused in fixedoverdenturerestorations that canbe attachedwith a snap-insystem. | The MiNi InternalImplant System isintended for two-stage surgicalprocedures in thefollowingsituations and withthe following clinicalprotocols:- The intended usefor the 3.0 mmdiameter MiNiimplant is limited tothe replacement ofmaxillary lateralincisors andmandibular incisors.- Immediateplacement inextraction sites andin situations with apartially orcompletelyhealed alveolar ridge.- It is intended fordelayed loading. | Osstem AbutmentSystem is intendedfor use with a dentalimplant to providesupport forprostheticrestorations such ascrowns, bridges, oroverdentures. | Meg-Ball AttachmentSystem, Meg-LocAbutment, Meg-Magnet Abutment isintended to be usedin theupper or lower jawand used forsupporting toothreplacements torestore chewingfunction. Intendedfor fully edentulousjaw retaining a tissuesupportedoverdenture.The abutments incombination withendosseous implantsare used as thefoundation foranchoring toothreplacements ineither jaw. Theattachments areused in fixedoverdenturerestorations that canbe attachedwith a snap-insystem. |
| Design | Image: Abutment Screw | Image: Octa Abutment Screw | Image: Multi-unit Abutment Screw | Design | |||||
| Diameter ( $Ø$ ) | 2.5, 2.6 mm | 2.5 mm | 2.95 mm | Diameter (Ø) | 3.89 mm | 3.89 mm | 3.0, 3.1, 3.4 mm | 3.5, 3.7, 4.1, 4.8,5.1 mm | 4.5, 5.0 mm |
| Total Length | 4.85, 5.5 mm | 4.85 mm | 11.5, 12.5, 13.5, 14.5, 15.5 mm | Total Length | 7.45, 7.95, 8.95,9.95, 10.95, 11.95,12.95, 13.95 mm | 7.45, 7.95, 8.95,9.95, 10.95, 11.95,12.95 mm | 6.55, 6.95, 7.25,7.75, 7.95, 8.40,8.75, 8.90, 8.95,9.75, 9.90, 9.95,10.75, 10.90,10.95, 11.75,11.90, 11.95,12.75, 12.90, 13.90mm | Unknown | 5.65, 5.85, 6.15,6.2, 6.75, 6.8,6.9, 7.15, 7.2,7.3, 7.4, 7.75,8.15, 8.2, 8.3,8.4, 8.75, 9.15,9.2, 9.3, 9.4,9.75, 10.15, 10.2,10.3, 10.4, 10.75,11.2, 11.3, 11.4,11.75 mm |
| ConnectionInterface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection | Gingival(Cuff) Height | 0.3, 0.8, 1.8, 2.8,3.8, 4.8, 5.8, 6.8mm | 0.3, 0.8, 1.8, 2.8,3.8, 4.8, 5.8 mm | 0.2, 0.3, 1.0, 2.0,3.0, 4.0, 5.0, 6.0mm | 1.0, 2.0, 3.0, 4.0,5.0, 6.0, 7.0 mm | 0.3, 0.8, 1.8, 2.8,3.8, 4.8, 5.8 mm |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | Post Height | 1.5 mm | 1.5 mm | 1.5, 1.7 mm | Unknown | N/A |
| SurfaceTreatment | Machined | Machined | Machined | AngulationConnection | Up to 20°Internal Conical | Up to 20°Internal Conical | StraightInternal Conical | StraightInternal Conical | StraightInternal Conical |
| Single Use | Yes | Yes | Yes | Interface | Connection | Connection | Connection | Connection | Connection |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Material | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) | Stainless Steel(ASTM F899-20) |
| Principle ofOperation | The Abutment Screw is used for connecting the Angled Abutment to the Fixture, and Healing Cap, Temporary Cylinder, EZ Post Cylinder, Gold Cylinder, CCM Cylinder to the Octa Abutment. | The Octa Abutment Screw is used for connecting the Healing Cap, Temporary Cylinder, EZ Post Cylinder, Gold Cylinder, CCM Cylinder to the Octa Abutment. | The Multi-unit Abutment Screw is used for connecting Multi-unit Abutment to the fixture. | SurfaceTreatment | Partial TiN coating | Machined | Machined | Partial TiN coating | Partial TiN coating |
| Single Use | Yes | Yes | Yes | Yes | Yes | ||||
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
1. Similarities
The subject device has the same characteristic for the followings compared to the reference devices.
Indication for use, Design, Connection Interface, Material, Surface Treatment, Single Use, Sterilization and Principle l of Operation.
2. Differences
The subject device has the different characteristic for the followings compared to the reference devices.
Diameter & Total Length -
The dimension of subject device is slightly different with reference devices, but the half are same as reference device 1, and the other half are lie within combined range of reference device 1&2. Also, it does not cause a matter in substantial equivalence since the size difference is very minor.
3. Discussion
Some of the proposed Abutment Screw had been FDA cleared under K123988 with product name of 'Octa Abutment -Screw', but it is being submitted to change their identifier with modification of product name only, and to add a new dimension. Therefore, the proposed Abutment Screw and reference device have common in all the items in the comparison chart except the Diameter and Total Length. These size differences are explained not affecting on the substantial equivalence.
On the basis of the discussion above, it is concluded that the substantially equivalent to the reference device.
{36}------------------------------------------------
Meg-Loc Abutment
{37}------------------------------------------------
| Principle of Operation | The Meg-Loc Abutment is generally applied to prosthetic procedure for overdentures. The head part is where connected to overdenture with attachment and the screw part is connected directly to the endosseous dental implant by their threaded part. | The Meg-Loc Abutment is generally applied to prosthetic procedure for overdentures. The head part is where connected to overdenture with attachment and the screw part is connected directly to the endosseous dental implant by their threaded part. | The Meg-Rhein Abutment is generally applied to prosthetic procedure for overdentures. The head part is where connected to overdenture with attachment and the screw part is connected directly to the endosseous dental implant by their threaded part. | The Port Abutment is generally applied to prosthetic procedure for overdentures. The head part is where connected to overdenture with attachment and the screw part is connected directly to the endosseous dental implant by their threaded part. | The Meg-Magnet Abutment is generally applied to prosthetic procedure for overdentures. The head part is where connected to overdenture with attachment and the screw part is connected directly to the endosseous dental implant by their threaded part. |
|---|---|---|---|---|---|
| ------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Substantial Equivalence Discussion
1. Similarities
The subject device has the same characteristic for the followings compared to the reference devices.
Indication for use, Design, Diameter, Post Height, Angulation, Connection Interface, Material, Single Use, Sterilization and Principle of Operation.
2. Differences
The subject device has the different characteristic for the followings compared to the reference devices.
Total Length and Gingival (Cuff) Height Almost all the total lengths and cuff height of subject device are same with the reference device 1. The only difference is that slight longer length(13.95mm) and cuff height(6.8mm) is added in the subject device but it is a very slight difference(0.5mm) between the longest length(13.9mm) of reference device2, and all the cuff height of subject device lie within combined range of reference device 1~4. The difference in cuff height is acceptable for the subject device as it is intended to be used with a tissue level implant, with a portion of the cuff height built into the implant, whereas the predicate device is intended to be used with a bone level implant which requires a cuff height for all abutments. Surface Treatment
The subject device is treated with partial Tin Coating in upper part while the reference device 1 is not applicable, but has same surface treatment as reference device 4 and Megagen's FDA cleared reference device 3.
3. Discussion
Some of the proposed Meg-Loc Abutment had been FDA cleared with K192614, but it is being submitted to change their identifier with modification of surface treatment, compatible implant system(ExFeel Internal→AnyOne Onestage), and to add a new dimension. Therefore, the proposed Meg-Loc Abutment and reference device have common in all the items in the comparison chart except the Total Length, Gingival (Cuff) Height and Surface Treatment. These differences are explained not affecting on the substantial equivalence.
This abutment can be used to correct divergence up to the angulation stated. The fatigue testing presented in this submission for the Angled Abutment was leveraged for the fatigue testing of this device. The Angled Abutment is considered an acceptable worse case for fatigue testing because it, the Meg-Loc abutments are all made of the same material, the Angled Abutment has a higher Angulation, and the Angled Abutment presents a higher moment arm than the overdenture type abutments.
On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference device.
{38}------------------------------------------------
Meg-Ball Abutment
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) No. | K210161 | K192614 | K182091 |
| Device Name(CompatibleImplantSystem) | Meg-Ball AbutmentFor AnyOne Onestage ImplantSystem | Meg-Ball AbutmentFor ExFeel Dental Implant System | Port AbutmentFor TS SA, SS SA, US SA, MS SAImplant |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Osstem Implant Co., Ltd. |
| Indicationsfor UseStatement | The AnyOne Onestage ImplantSystem is intended to be surgicallyplaced in the maxillary or mandibulararches for the purpose of providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing functionin the following situations and withthe clinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved and withappropriate occlusal loading. Largerimplants are dedicated for the molarregion. | Meg-Ball Attachment System, Meg-Loc Abutment, Meg-MagnetAbutment is intended to be used inthe upper or lower jaw and used forsupporting tooth replacements torestore chewing function. Intendedfor fully edentulous jaw retaining atissue supported overdenture.The abutments in combination withendosseous implants are used as thefoundation for anchoring toothreplacements in either jaw. Theattachments are used in fixedoverdenture restorations that can beattached with a snap-in system. | Osstem Abutment System is intendedfor use with a dental implant toprovide support for prostheticrestorations such as crowns, bridges,or overdentures. |
| Design | Image: Subject Device Design | Image: Reference Device 1 Design | Image: Reference Device 2 Design |
| HeadDiameter (Ø) | 2.25 mm | 2.25 mm | N/A |
| Head Height(Post Height) | 4.15 mm | 4.15 mm | Unknown |
| Diameter (Ø) | 3.5 mm | 3.5 mm | 3.5, 3.7, 4.1, 4.8, 5.1 mm |
| Total Length | 10.1, 10.6, 11.6, 12.6, 13.6, 14.6,15.6, 16.6 mm | 10.1, 10.6, 11.6, 12.6, 13.6, 14.6,15.6 mm | Unknown |
| GingivalHeight | 0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8,6.8mm | 0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8 mm | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 mm |
| Angulation | Up to 15° | Up to 15° | Straight |
| ConnectionInterface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) |
| SurfaceTreatment | Machined | Machined | Partial TiN coating |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle ofOperation | The Meg-Ball Abutment isgenerally applied to prostheticprocedure for overdentures. Thehead part is where connected tooverdenture with attachmentand the screw part is connecteddirectly to the endosseous dentalimplant by their threaded part. | The Meg-Ball Abutment isgenerally applied to prostheticprocedure for overdentures. Thehead part is where connected tooverdenture with attachmentand the screw part is connecteddirectly to the endosseous dentalimplant by their threaded part. | The Port Abutment is generallyapplied to prosthetic procedurefor overdentures. The head part iswhere connected to overdenturewith attachment and the screwpart is connected directly to theendosseous dental implant bytheir threaded part. |
| Substantial Equivalence Discussion | |||
| 1. SimilaritiesThe subject device has the same characteristic for the followings compared to the reference devices.Indication for use, Design, Head Diameter, Head Length (Post Height), Diameter, Angulation, Connection Interface,Material, Surface Treatment, Single Use, Sterilization and Principle of Operation.2. DifferencesThe subject device has the different characteristic for the followings compared to the reference devices.Total Length and Gingival (Cuff) Height |
difference is that slight longer length(16.6mm) and cuff height(6.8mm) is added in the subject device, but the difference in cuff height is acceptable for the subject device as it is intended to be used with a tissue level implant, with a portion of the cuff height built into the implant, whereas the predicate device is intended to be used with a bone level implant which requires a cuff height for all abutments, and all the cuff height of subject device lie within combined range of reference device 1&2.
{39}------------------------------------------------
3. Discussion
Some of the proposed Meg-Ball Abutment had been FDA cleared with K192614, but it is being submitted to change their identifier with modification of, compatible implant system(ExFeel Internal→AnyOne Onestage), and to add a new dimension. Therefore, the proposed Meg-Ball Abutment and reference device have common in all the items in the comparison chart except the Total Length and Gingival (Cuff) Height. These size differences are explained not affecting on the substantial equivalence. This abutment can be used to correct divergence up to the angulation stated. The fatigue testing presented in this submission for the Angled Abutment was leveraged for the fatigue testing of this device. The Angled Abutment is considered an acceptable worse case for fatigue testing because it, the Meg-Loc abutments are all made of the same material, the Angled Abutment has a higher Angulation, and the Angled Abutment presents a higher moment arm than the overdenture type abutments.
On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference device.
{40}------------------------------------------------
Meg-Magnet Abutment
| Subject Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | |
|---|---|---|---|---|
| 510(k) No. | K210161 | K192614 | K192614 | K182091 |
| Device Name(CompatibleImplantSystem) | Meg-Magnet AbutmentFor AnyOne OnestageImplant System | Meg-Magnet AbutmentFor ExFeel Dental ImplantSystem | Meg-Loc AbutmentAnyRidge, AnyOne,AnyRidge Octa 1, ExFeelInternal Implant System | Port AbutmentFor TS SA, SS SA, US SA, MSSA Implant |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Osstem Implant Co., Ltd. |
| Indicationsfor UseStatement | The AnyOne OnestageImplant System is intendedto be surgically placed inthe maxillary or mandibulararches for the purpose ofproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function in thefollowing situations andwith the clinical protocols:-Delayed loading.-Immediate loading whengoodprimary stability is achievedand with appropriateocclusal loading. Largerimplants are dedicated forthe molar region. | Meg-Ball AttachmentSystem, Meg-LocAbutment, Meg-MagnetAbutment is intended to beused in the upper or lowerjaw and used forsupporting toothreplacements to restorechewing function. Intendedfor fully edentulous jawretaining a tissue supportedoverdenture.The abutments incombination withendosseous implants areused as the foundation foranchoring toothreplacements in either jaw.The attachments are usedin fixed overdenturerestorations that can beattached with a snap-insystem. | Meg-Ball AttachmentSystem, Meg-LocAbutment, Meg-MagnetAbutment is intended to beused in the upper or lowerjaw and used forsupporting toothreplacements to restorechewing function. Intendedfor fully edentulous jawretaining a tissue supportedoverdenture.The abutments incombination withendosseous implants areused as the foundation foranchoring toothreplacements in either jaw.The attachments are usedin fixed overdenturerestorations that can beattachedwith a snap-in system. | Osstem Abutment Systemis intended for use with adental implant to providesupport for prostheticrestorations such ascrowns, bridges, oroverdentures. |
| Design | ||||
| Diameter (Ø) | 4.5, 5.0 mm | 4.5, 5.0 mm | 3.89 mm | 3.5, 3.7, 4.1, 4.8, 5.1 mm |
| Total Length | 6.20, 6.25, 6.75, 7.20,7.75, 8.20, 8.75, 9.20,9.75, 10.20, 10.75,11.20, 11.75, 12.20,12.75 mm | 6.20, 6.75, 7.20, 7.75,8.20, 8.75, 9.20, 9.75,10.20, 10.75, 11.20,11.75 mm | 6.85, 7.35, 7.45, 7.95, 8,8.1, 8.35, 8.5, 8.6, 8.95,9.35, 9.5, 9.6, 9.95,10.35, 10.5, 10.6, 10.95,11.35, 11.5, 11.6, 11.95,12.35, 12.5, 12.6, 12.95,13.5, 13.6 mm | Unknown |
| GingivalHeight | 0.3, 0.8, 1.8, 2.8, 3.8,4.8, 5.8, 6.8mm | 0.3, 0.8, 1.8, 2.8, 3.8,4.8, 5.8 mm | 0.3, 0.8, 1.8, 2.8, 3.8,4.8, 5.8 mm | 1.0, 2.0, 3.0, 4.0, 5.0,6.0, 7.0 mm |
| AngulationConnection | StraightInternal Conical | StraightInternal Conical | StraightInternal Conical | StraightInternal Conical |
| Interface | Connection | Connection | Connection | Connection |
| Material | Stainless Steel(ASTM F899-20) | Stainless Steel(ASTM F899-20) | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) |
| SurfaceTreatment | Partial TiN coating | Partial TiN coating | Machined | Partial TiN coating |
| Single Use | Yes | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Principle ofOperation | TheMeg-MagnetAbutment is generallyapplied to prostheticprocedureforoverdentures. The headpart is where connectedtooverdenture withattachmentand thescrew part is connecteddirectlytotheendosseousdentalimplant by theirthreaded part. | TheMeg-MagnetAbutment is generallyapplied to prostheticprocedureforoverdentures. The headpart is where connectedtooverdenture withattachmentand thescrew part is connecteddirectlytotheendosseousdentalimplant by theirthreaded part. | The Meg-Loc Abutmentis generally applied toprosthetic procedure foroverdentures. The headpart is where connectedtooverdenture withattachmentand thescrew part is connecteddirectly to theendosseous dentalimplant by theirthreaded part. | The Port Abutment isgenerally applied toprosthetic procedure foroverdentures. The headpart is where connectedto overdenture withattachment and thescrew part is connecteddirectly to theendosseous dentalimplant by theirthreaded part. |
{41}------------------------------------------------
Substantial Equivalence Discussion
1. Similarities
- The subject device has the same characteristic for the followings compared to the reference devices.
- Indication for use, Design, Diameter, Angulation Interface, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation.
2. Differences
The subject device has the different characteristic for the followings compared to the reference devices.
Total Length and Gingival (Cuff) Height
Almost all the total lengths and cuff height of subject device are same with the reference device 1. The only difference is that slight longer length (6.25, 12.2, 12.75 mm) and cuff height(6.8mm) is added in the subject device, but all the dimensions lie within combined range of reference device 1&2. The difference in cuff height is acceptable for the subject device as it is intended to be used with a tissue level implant, with a portion of the cuff height built into the implant, whereas the predicate device is intended to be used with a bone level implant which requires a cuff height for all abutments.
3. Discussion
Some of the proposed Meg-Magnet Abutment had been FDA cleared with K192614, but it is being submitted to
change their identifier with modification of, compatible implant system(ExFeel Internal→AnyOne Onestage), and to add a new dimension. Therefore, the proposed Meg-Magnet Abutment and reference device have common in all the items in the comparison chart except the Total Length and Gingival (Cuff) Height. These size differences are explained not affecting on the substantial equivalence. Also, the additional fatigue testing is not considered based on FDA Guidance Document being as proposed abutment is straight type. The subject abutment is intended for straight implantation, and is not received single load, because it used for supporting that means load is dispersed to the full denture. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference device.
{42}------------------------------------------------
Magnet
:
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) No. | K210161 | K192614 | K192614 |
| Device Name(Compatible ImplantSystem) | MagnetFor AnyOne Onestage ImplantSystem | Metal HousingAnyRidge Internal ImplantSystem, AnyOne Internal ImplantSystem, AnyRidge Octa 1 ImplantSystem | Meg-Magnet AbutmentForAnyRidge, AnyOne, AnyRidgeOcta 1, ExFeel Internal ImplantSystem |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for UseStatement | The AnyOne Onestage ImplantSystem is intended to besurgically placed in the maxillaryor mandibular arches for thepurpose of providing prostheticsupport for dental restorations(Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is usedto restore a patient's chewingfunction in the followingsituations and with the clinicalprotocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved andwith appropriate occlusal loading.Larger implants are dedicated forthe molar region. | Meg-Ball Attachment System,Meg-Loc Abutment, Meg-MagnetAbutment is intended to be usedin the upper or lower jaw andused for supporting toothreplacements to restore chewingfunction. Intended for fullyedentulous jaw retaining a tissuesupported overdenture. Theabutments in combination withendosseous implants are used asthe foundation for anchoringtooth replacements in either jaw.The attachments are used in fixedoverdenture restorations thatcan be attached with a snap-insystem. | Meg-Ball Attachment System,Meg-Loc Abutment, Meg-MagnetAbutment is intended to be usedin theupper or lower jaw and used forsupporting tooth replacements torestore chewing function.Intended for fully edentulous jawretaining a tissue supportedoverdenture.The abutments in combinationwith endosseous implants areused as the foundation foranchoring toothreplacements in either jaw. Theattachments are used in fixedoverdenture restorations thatcan be attachedwith a snap-in system. |
| Design | Image: [design] | Image: [design] | Image: [design] |
| Diameter (Ø) | 4.5, 5.0 mm | 5.0 mm | 4.5, 5.0 mm |
| Total Length | 2.2 mm | 4.0 mm | 5.65, 5.85, 6.15, 6.2, 6.75, 6.8,6.9, 7.15, 7.2, 7.3, 7.4, 7.75,8.15, 8.2, 8.3, 8.4, 8.75, 9.15,9.2, 9.3, 9.4, 9.75, 10.15, 10.2,10.3, 10.4, 10.75, 11.2, 11.3,11.4, 11.75 mm |
| Material | Stainless Steel(ASTM F899-20) | Ti-6Al-4V ELI (ASTM F136-13) | Stainless Steel(ASTM F899-20) |
| Surface Treatment | TiN coating | Machined | TiN coating |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle of Operation | The Magnet is generallyapplied to prostheticprocedure for overdentures. Itis inserted and fixed intodenture; and applied to Meg-Magnet Abutment to stabilizethe overdenture using itsmagnetic force. | The Metal housing is generallyapplied to prostheticprocedure for overdentures.It is inserted and fixed intodenture; and applied to balltype abutment to stabilize theoverdenture. | The Meg-Magnet Abutment isgenerally applied to prostheticprocedure for overdentures.The head part is whereconnected to overdenturewith attachment and thescrew part is connecteddirectly to the endosseousdental implant by theirthreaded part. |
| Substantial Equivalence Discussion | |||
| 1. SimilaritiesThe subject device has the same characteristic for the followings compared to the reference devices.Indication for use, Design, Single Use, Sterilization and Principle of Operation | |||
| 2. DifferencesThe subject device has the different characteristic for the followings compared to the reference devices.Diameter, Total Length- The dimension of subject device is slightly different with reference device 1, but it is due to the difference ofcompatible abutment. Also, it does not cause a matter in substantial equivalence since the size difference is veryminor.Material, Surface Treatment- The material and surface treatment of subject device is different with reference device 1, but has made with samematerial and surface treatment with reference device 2. |
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3. Discussion
The proposed Magnet and reference device 1 have common in all the items in the comparison chart except the 1 Diameter, Total Length, Material and Surface Treatment. These differences are not affecting on the substantial equivalence since the variety of the size can be possible to operate more precise treatment to meet each patient's condition and the material and surface treatment same as MegaGen's reference device 2. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference device.
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Meg-Rhein Abutment
| Subject Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | |
|---|---|---|---|---|
| 510(k) No. | K210161 | K150537 | K182091 | K192614 |
| Device Name(CompatibleImplantSystem) | Meg-Rhein AbutmentFor AnyOne OnestageImplant System | Meg-Rhein AbutmentFor MiNi Internal ImplantSystem | Port AbutmentFor TS SA, SS SA, US SA, MSSA Implant | Meg-Magnet AbutmentFor AnyRidge, AnyOne,AnyRidge Octa 1, ExFeelInternal Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Osstem Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indicationsfor UseStatement | The AnyOne OnestageImplant System is intendedto be surgically placed inthe maxillary or mandibulararches for the purpose ofproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function in thefollowing situations andwith the clinical protocols:-Delayed loading.-Immediate loading whengoodprimary stability is achievedand with appropriateocclusal loading. Largerimplants are dedicated forthe molar region. | The MiNi Internal ImplantSystem is intended for two-stage surgical procedures inthe following situations andwith the following clinicalprotocols:- The intended use for the3.0 mm diameter MiNiimplant is limited to thereplacement ofmaxillary lateral incisorsand mandibular incisors.- Immediate placement inextraction sites and insituations with a partially orcompletelyhealed alveolar ridge.- It is intended for delayedloading. | Osstem Abutment Systemis intended for use with adental implant to providesupport for prostheticrestorations such ascrowns, bridges, oroverdentures. | Meg-Ball AttachmentSystem, Meg-LocAbutment, Meg-MagnetAbutment is intended to beused in the upper or lowerjaw and used forsupporting toothreplacements to restorechewing function. Intendedfor fully edentulous jawretaining a tissue supportedoverdenture.The abutments incombination withendosseous implants areused as the foundation foranchoring toothreplacements in either jaw.The attachments are usedin fixed overdenturerestorations that can beattached with a snap-insystem. |
| Design | ||||
| HeadDiameter (Ø) | 2.5mm | 2.5 mm | Unknown | N/A |
| Head Height(Post Height) | 1.7 mm | 1.5, 1.7 mm | Unknown | N/A |
| Diameter (Ø) | 3.5 mm | 3.0, 3.1, 3.4 mm | 3.5, 3.7, 4.1, 4.8, 5.1 mm | 4.5, 5.0mm |
| Total Length | 7.45, 9.15, 11.15, 13.15mm | 6.55, 6.95, 7.25, 7.75,7.95, 8.40, 8.75, 8.90,8.95, 9.75, 9.90, 9.95,10.75, 10.90, 10.95,11.75, 11.90, 11.95,12.75, 12.90, 13.90 mm | Unknown | 5.65, 5.85, 6.15, 6.2,6.75, 6.8, 6.9, 7.15, 7.2,7.3, 7.4, 7.75, 8.15, 8.2,8.3, 8.4, 8.75, 9.15, 9.2,9.3, 9.4, 9.75, 10.1510.2, 10.3, 10.4, 10.75,11.2, 11.3, 11.4, 11.75mm |
| GingivalHeight | 0.3, 2.0, 4.0, 6.0 mm | 0.2, 0.3, 1.0, 2.0, 3.0,4.0, 5.0, 6.0 mm | 1.0, 2.0, 3.0, 4.0, 5.0,6.0, 7.0 mm | 0.3, 0.8, 1.8, 2.8, 3.8,4.8, 5.8mm |
| Angulation | Straight | Straight | Straight | Straight |
| Connection | Internal Conical | Internal Conical | Internal Conical | Internal Conical |
| Interface | Connection | Connection | Connection | Connection |
| Material | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) | Stainless Steel(ASTM F899-20) |
| SurfaceTreatment | 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 ofOperation | TheMeg-RheinAbutment is generallyto prostheticappliedproceduretoroverdentures. The headpart is where connectedoverdenturewithtoattachmentandthescrew part is connecteddirectlytotheendosseousdentalimplantbytheirthreaded part. | TheMeg-RheinAbutment is generallyto prostheticappliedproceduretoroverdentures. The headpart is where connectedoverdenturetowithattachmentandthescrew part is connecteddirectlytotheendosseousdentalimplantbytheirthreaded part. | The Port Abutment isgenerally appliedtoprosthetic procedure foroverdentures. The headpart is where connectedoverdenturetowithattachmentandthescrew part is connecteddirectlytothedentalendosseousimplantbytheirthreaded part. | Meg-MagnetTheAbutment is generallyapplied to prostheticproceduretoroverdentures. The headpart is where connectedoverdenturewithtoattachmentandthescrew part is connecteddirectlytotheendosseousdentalimplantbytheirthreaded part. |
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Substantial Equivalence Discussion 1. Similarities The subject device has the same characteristic for the followings compared to the reference devices. Indication for use, Design, Head Diameter, Head Height (Post Height), Gingival (Cuff) Height, Angulation, Connection Interface, Material, Single Use, Sterilization and Principle of Operation. 2. Differences The subject device has the different characteristic for the followings compared to the reference devices. Diameter and Total Length The diameter and total length of subject device is slightly different with reference device 1, but it lies within combined range of reference devices 1~3. The difference in cuff height is acceptable for the subject device as it is intended to be used with a tissue level implant, with a portion of the cuff height built into the implant, whereas the predicate device is intended to be used with a bone level implant which requires a cuff height for all abutments. -Surface Treatment The subject device is treated with partial Tin Coating in upper part while the reference device 1 is not applicable, but has same surface treatment as reference device 2 and Megagen's FDA cleared reference device 3. 3. Discussion The proposed Meg-Rhein Abutment is being submitted to add in Megager's existing prothein had
been FDA cleared. Therefore, the proposed Meg-Rhein Abutment and reference device items in the comparison chart except the Diameter, Total Length and Surface Treatment. These differences are explained not affecting on the substantial equivalence. Also, the additional fatigue testing is not considered based on FDA Guidance Document being as proposed abutment is straight type. The subject abutment is intended for straight implantation, and is not received single load, because it used for supporting that means
load is dispersed to the full denture. On the basis of the discussion above, it is concluded that the subject device is
substantially equivalent to the reference device.
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Summary of Non-Clinical Testing 8.
The non-clinical testing data which are submitted, referenced, or relied on in this submission support demonstrating substantial equivalence.
Biocompatibility
The biocompatibility evaluation has been performed in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
The additional biocompatibility testing is not required on the AnyOne Onestage Implant System since AnyOne Onestage Implant System has same material composition, manufacturing process and patient contacting parts as predicate device, AnyRidge Octa 1 Implant System (K182448), ExFeel Dental Implant System (K052369), AnyOne Internal Implant System (K123988) and Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment (K19614).
Modified Surface Treatment
The surface treatment evaluation has been performed in accordance with 'Section 11 of Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'.
AnyOne Onestage Implant System has same surface treatment and manufacturing process as predicate device, AnyRidge Octa 1 Implant System (K182448) and ExFeel Dental Implant System (K052369) for the surface treatment of S.L.A and Anodizing, and Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment (K19614) for TiN coating.
Pyrogen and Endotoxin Test
The subject device will not be labeled as "non-pyrogenic", and the endotoxin testing will be conducted on every batch for the subject device with the testing limit of below 0.5 EU/mL in accordance with the USP 39 <85>.
Sterilization validation
Sterilization validating testing has been performed in accordance with ISO 11137 and ISO 17665-1, 2 to verify the sterility assurance level (104). The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980 and the test results validated 5 years shelf life.
Also, the following guidance documents were referred to:
- . Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Performance (Physical Properties) Test
The following bench tests have been performed in accordance with "ISO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment" to evaluate the performance of the subject devices and the test results met the pre-set criteria.
- . Static compression-strength test
- . Fatigue test
9. Summary of Clinical Testing
No clinical studies are submitted.
10. Conclusion
Based on the information provided in this premarket notification, We, MegaGen Implant Co., Ltd. conclude that the AnyOne Onestage Implant System is substantially equivalent to the predicate device as herein.
§ 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.