TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment

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MegaGen Implant Co., Ltd. % Hyo-Eun Lee Assistant Research Engineer DaeGyeong Regulatory Affairs Institute 32, Innovalley-ro Daegu, Dong-gu 41065 REPUBLIC OF KOREA Re: K220562 Trade/Device Name: TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 7, 2022 Received: October 11, 2022 Dear Hyo-Eun Lee: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Andrew I. Steen -S Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220562 Device Name TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment Indications for Use (Describe) The TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation. For TiGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture. | Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 5px;"></span> <label><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </span> <span> <span style="padding-left: 20px; padding-right: 5px;"></span> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </span> | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Applicant / Submitter MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea Tel: + 82-53-222-2828 # 2. Submission Correspondent Hyo-Eun Lee MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea Tel: +82-53-222-3860 Fax: Fax: +82-53-289-3420 Email: ra7@imegagen.com # 3. Device | • Trade Name | TiGEN Abutment,<br>ZrGEN Abutment and<br>Scan Healing Abutment | |-------------------------------|----------------------------------------------------------------| | • Common Name | Endosseous dental implant abutment | | • Classification Name | Endosseous dental implant abutment | | • Classification Product Code | NHA | | • Classification regulation | Class II, 21 CFR 872.3630 | # 4. Predicate Device • Primary Predicate Device: K150203 Medentika CAD/CAM Abutments # • Reference Device: K122231 XPEED AnyRidge Internal Implant System K123988 AnyOne Internal Implant System K150537 MiNi Internal Implant System K171622 Dentium Ti-Base K110955 AnyRidge Internal Implant System K173374 TSV™ BellaTek® Encode® Healing Abutments K182448 AnyRidge Octa 1 Implant System {4}------------------------------------------------ # 5. Description The TiGEN Abutment is machined with the final prosthetic in accordance with the intraoral structure. It is machined by using dental CAD/CAM technology in accordance with customized patient's information in MegaGen-validated milling center. The TiGEN Abutment is made of Ti-6Al-4V ELI alloy. And It is provided with abutment screw. All TiGEN Abutment is provided non-sterile. The milled TiGEN Abutment must be sterilized by users prior to use. The dimensions of TiGEN Abutment are follows: | Standard Type | Total length (mm) | 28.00, 28.40, 28.60, 28.70, 28.90, 29.05, 30.55 | |-----------------|-------------------|-------------------------------------------------| | | Diameter (mm) | 10.00, 12.00 | | Octa level Type | Total length (mm) | 26.00 | | | Diameter (mm) | 10.00, 12.00 | The allowable ranges of design parameters after CAD/CAM patient-matching are follows: | Standard Type | Minimum wall thickness (mm) | 0.47 | |-----------------|-------------------------------------|------------------| | | Maximum angulation (°) | 30 | | | Minimum gingival collar height (mm) | 2.00 | | | Maximum gingival collar height (mm) | 5.00 | | | Minimum gingival collar (ø) | 3.50, 4.00, 4.50 | | | Maximum gingival collar (ø) | 9.50, 11.50 | | | Minimum post height (mm) | 4.00 | | | Maximum post height (mm) | 6.00, 6.50 | | Octa level Type | Minimum wall thickness (mm) | 0.47 | | | Maximum angulation (°) | 30 | | | Minimum gingival collar (ø) | 4.00 | | | Maximum gingival collar (ø) | 9.50, 11.50 | | | Minimum post height (mm) | 4.00 | | | Maximum post height (mm) | 6.00 | The TiGEN Abutment is compatible with following MEGAGEN Implants and Screw cleared under: | Type | Name | Dental Implant | | Octa Abutment | | Screw | | | |--------------------|---------------------------------------|--------------------------------------------------------|------------------------------------|---------------------------------|--------------------------------|------------------|------------------|----------------------| | | | The widest<br>diameter (mm) | Platform<br>Diameter<br>(mm) | 510(k)<br>Number | Connection<br>Diameter<br>(mm) | 510(k)<br>Number | 510(k)<br>Number | Model<br>Name | | Standard<br>Type | XPEED<br>AnyRidge<br>Internal Fixture | 4.0, 4.4, 4.9, 5.4,<br>5.9, 6.4, 6.9, 7.4,<br>7.9, 8.4 | 2.31, 2.8,<br>3.1, 3.3 | K122231,<br>K123870,<br>K140091 | - | - | K110955 | AANMSF | | | AnyOne<br>Internal Fixture | 3.9, 4.3, 4.8, 5.3,<br>5.8, 6.3, 6.8, 7.3,<br>7.8, 8.3 | | K123988 | - | - | K123988 | AS20 | | | MINi Internal<br>Fixture | 3.0, 3.4 | | K150537 | - | - | K150537 | MIAS14 | | | AnyRidge Octa<br>1 Fixture | 3.6, 4.0, 4.4, 4.7,<br>4.8, 5.0, 5.5 | | K182448 | - | - | K182448 | AROAS16B,<br>AROAS16 | | Octa Level<br>Type | XPEED<br>AnyRidge<br>Internal Fixture | 4.0, 4.4, 4.9, 5.4,<br>5.9, 6.4, 6.9, 7.4,<br>7.9, 8.4 | 3.8, 4.0,<br>4.8, 5.0,<br>5.8, 6.0 | K122231,<br>K123870,<br>K140091 | 4.0, 5.0, 6.0 | K110955 | K123988 | | | | AnyOne<br>Internal Fixture | 3.9, 4.3, 4.8, 5.3,<br>5.8, 6.3, 6.8, 7.3,<br>7.8, 8.3 | | K123988 | 3.8, 4.8, 5.8 | K123988 | | IRCS200 | | | AnyRidge Octa<br>1 Fixture | 3.6, 4.0, 4.4, 4.7,<br>4.8, 5.0, 5.5 | | K182448 | 4.0, 5.0, 6.0 | K182448 | | | {5}------------------------------------------------ The ZrGEN Abutment is a two-piece abutment composed of the stock titanium base cemented together with the zirconia top-half to complete the final finished device. This abutment is to be used only with implants placed straight. It is made of Ti-6Al-4V ELI alloy. It is provided with abutment screw. All ZrGEN Abutment is provided non-sterile. Therefore, the ZrGEN Abutment must be sterilized by users prior to use after the cementation of the Zirconia top-half. | Standard Type | Total length (mm) | 5.10, 5.50, 7.50, 7.70, 8.00, 8.15, 8.40, 8.60, 8.90, 9.00, 9.05, 9.20, 9.50, 9.65, 9.90, 10.10, 10.40, 10.55, 11.15, 11.55, 11.65, 12.05, 12.55, 13.05, 13.15, 13.55, 14.05, 14.55, 15.05, 15.55, 16.55 | |-----------------|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Diameter (mm) | 3.1, 4.0, 4.4, 4.5, 5.0, 5.5, 6.0 | | C- Type | Total length (mm) | 7.9, 8.2, 8.35, 8.4, 8.7, 8.85, 9.4, 9.7, 9.85, 10.35, 11.35 | | | Diameter (mm) | 3.9, 4.3, 5.5 | | Octa level Type | Total length (mm) | 5.80 | | | Diameter (mm) | 5.0, 5.5, 6.5 | The dimensions of ZrGEN Abutment are follows: | | | | The allowable ranges of design parameters after CAD/CAM patient-matching are follows: | | |--|--|--|---------------------------------------------------------------------------------------|--| | | | | | | | | | ZrGEN Abutment<br>(Standard Type) | Minimum wall thickness (mm) | 0.4, 0.41, 0.43, 0.5, 0.55, 0.8, 1.05, 1.18 | |----------|---------------|-------------------------------------|-------------------------------------|---------------------------------------------| | | | | Maximum angulation (°) | 0 | | | | | Minimum gingival collar (Ø) | 2.2, 3.15, 3.25, 3.75, 4.25, 4.5 | | | | | Maximum gingival collar (Ø) | 3.1, 4.0, 4.4, 4.5, 5.0, 5.5, 6.0 | | | | | Minimum post height (mm) | 1.2, 3.2, 4.7, 6.7 | | | | | Maximum post height (mm) | 2.5, 4.5, 6.0, 8.0 | | | | ZrGEN Abutment<br>(C-Type) | Minimum wall thickness (mm) | 0.12, 0.15,0.22, 0.32, 0.35, 0.42 | | | | | Maximum angulation (°) | 0 | | | titanium base | | Minimum gingival collar (Ø) | 3, 3.4 | | | | | | Maximum gingival collar (Ø) | | | | | | Minimum post height (mm) | | | | | | Maximum post height (mm) | | Zirconia | | ZrGEN Abutment<br>(Octa level type) | Minimum wall thickness (mm) | 0.75, 0.85, 1.35 | | Abutment | | | | Maximum angulation (°) | | | | | | Minimum gingival collar (Ø) | | | | | | Maximum gingival collar (Ø) | | | | | | Minimum post height (mm) | | | | | | Maximum post height (mm) | | | | | Minimum wall thickness (mm) | 0.5 | | | | | Maximum angulation (°) | 0 | | | | | Minimum gingival collar (Ø) | 8 | | | | zirconia top-half | Maximum gingival collar (Ø) | 10 | | | | | Minimum Gingival collar height (mm) | 2 | | | | | Maximum Gingival collar height (mm) | 5 | | | | | Minimum post height (mm) | 7 | | | | | Maximum post height (mm) | 15 | | | | | | | # The ZrGEN Abutment is compatible with following MEGAGEN Implants and Screw cleared under: | Type | Name | Dental Implant | | Octa Abutment | | Screw | | |-----------------------|------------------------------------|------------------------------------------------------|------------------------------|---------------------------------|--------------------------------|------------------|----------------------| | | | The widest diameter<br>(mm) | Platform<br>Diameter<br>(mm) | 510(k)<br>Number | Connection<br>Diameter<br>(mm) | 510(k)<br>Number | Model<br>Name | | Standard<br>Type | XPEED AnyRidge<br>Internal Fixture | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4,<br>6.9, 7.4, 7.9, 8.4 | - | K122231,<br>K123870,<br>K140091 | - | K110955 | AANMSF | | | AnyOne Internal<br>Fixture | 3.9, 4.3, 4.8, 5.3, 5.8,<br>6.3, ,6.8, 7.3, 7.8, 8.3 | - | K123988 | - | K123988 | AS20 | | | MINi Internal<br>Fixture | 3.0, 3.4 | 2.31, 2.8,<br>3.1, 3.3 | K150537 | - | K150537 | MIAS14 | | | AnyRidge Octa 1<br>Fixture | 3.6, 4.0, 4.4, 4.7, 4.8,<br>5.0,5.5 | - | K182448 | - | K182448 | AROAS16B,<br>AROAS16 | | C-Type | XPEED AnyRidge<br>Internal Fixture | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4,<br>6.9, 7.4, 7.9, 8.4 | - | K122231,<br>K123870,<br>K140091 | - | K110955 | AANMSF | | | AnyOne Internal<br>Fixture | 3.9, 4.3, 4.8, 5.3, 5.8,<br>6.3, ,6.8, 7.3, 7.8, 8.3 | - | K123988 | - | K123988 | AS20 | | | AnyRidge Octa 1<br>Fixture | 3.6, 4.0, 4.4, 4.7, 4.8, 5.0,<br>5.5 | - | K182448 | - | K182448 | AROAS16B,<br>AROAS16 | | Octa<br>Level<br>Type | XPEED AnyRidge<br>Internal Fixture | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4,<br>6.9, 7.4, 7.9, 8.4 | 3.8, 4.0, | K122231,<br>K123870,<br>K140091 | 4.0, 5.0,<br>6.0 | K110955 | - | | | AnyOne Internal<br>Fixture | 3.9, 4.3, 4.8, 5.3, 5.8,<br>6.3, ,6.8, 7.3, 7.8, 8.3 | 4.8, 5.0,<br>5.8, 6.0 | K123988 | 3.8, 4.8,<br>5.8 | K123988 | IRCS200 | | | AnyRidge Octa 1<br>Fixture | 3.6, 4.0, 4.4, 4.7, 4.8, 5.0,<br>5.5 | - | K182448 | 4.0, 5.0,<br>6.0 | K182448 | - | {6}------------------------------------------------ The Scan Healing Abutment designed to aid in soft tissue contouring the healing period after implant placement, creating an emergence profile for the final prosthesis. And they have the added design feature to be scannable an intraoral impression by digital scanner. The Scan Healing Abutment is provided with abutment screw and is provided gamma-sterile. A groove is added to the top part to check the diameter, and to the connection part to check the correct connection with the fixture. And notches are added to check height (area excluding the length of the connection area from the total length). The detail information of groove and notch is below. | Diameter (Ø, mm) | 4.2 | 4.7 | 5.7 | | |------------------|-----------------|------------|------------|--------------| | Groove | 0 | 1 | 2 | | | Height<br>(mm) | AnyRidge | 6.9 | 7.9 | 9.9 | | | AnyOne | 6.7 | 7.7 | 9.7 | | | AnyRidge Octa 1 | 7.35, 8.85 | 8.35, 9.85 | 10.35, 11.85 | | Notch | 0 | 1 | 2 | | | Anodizing | Gold | NA | Green | | The dimensions of scan Healing Abutment are follows: | Total length (mm) | 6.9, 6.7, 7.35, 7.7, 7.9, 8.35, 8.85, 9.79, 9.9, 10.35, 11.85 | |-------------------|---------------------------------------------------------------| | Diameter (mm) | 4.2, 4.7, 5.7, 6.7 | The Scan Healing Abutment is compatible with following MEGAGEN Implants and Screw cleared under: | Compatible Implant<br>System | Device Name | 510(k)<br>Number | The widest Diameter<br>(mm) | Model Name | |-------------------------------------------|------------------------------------|-------------------------------|-----------------------------------------------------|------------------------------------| | Xpeed AnyRidge<br>Internal Implant System | Xpeed AnyRidge<br>Internal Fixture | K122231<br>K123870<br>K140091 | 4.0, 4.4, 4.9, 5.4, 5.9,<br>6.4, 6.9, 7.4, 7.9, 8.4 | ARIHS1804, ARIHS1805,<br>ARIHS1807 | | AnyOne<br>Internal Implant System | AnyOne<br>Internal Fixture | K123988 | 3.9, 4.3, 4.8, 5.3, 5.8,<br>6.3, 6.8, 7.3, 7.8, 8.3 | AOIHS2004, AOIHS2005,<br>AOIHS2007 | | AnyRidge Octa 1 Implant<br>System | AnyRide Octa 1<br>Fixture | K182448 | 3.6, 3.7, 4.0, 4.1, 4.4,<br>4.8, 5.0, 5.5 | AROHS1604, AROHS1605,<br>AROHS1607 | # 6. Indication for use The TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation. For TiGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture. {7}------------------------------------------------ # 7. Basis for Substantial Equivalence | 7.1. Comparison of the Indications for Use | | | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|-------------------------|--------------------------------| | Subject Device | Table of Substantial Equivalence - Indications for Use<br>Indications for Use | | | | | MegaGen Co., Ltd. | The TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment are intended for use on endosseous dental<br>implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation. | | | | | | For TIGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and<br>ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture. | | | | | Predicate Device | Indications for Use | | | | | Medentika GmbH | Medentika Preface CAD/CAM Abutments are intended for use with dental implants as a support for single or<br>multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. | | | | | Medentika<br>CAD/CAM<br>Abutments<br>K150203 | Implant System Compatibility | Series | Implant Diameter (mm) | Platform Diameter (mm) | | | Nobel Biocare Replace™ Select | E | 3.5, 4.3, 5.0, 6.0 | 3.5, 4.3, 5.0, 6.0 | | | Nobel Biocare NobelActive™ | F | 3.0, 3.5, 4.3, 5.0 | 3.0, 3.5, 3.9 (4.3), 3.9 (5.0) | | | Biomet 3i Osseotite® Certain® | H | 3.24, 4.0, 5.0 | 3.4, 4.1, 5.0 | | | Biomet 3i Osseotite® | I | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 | | | Nobel Biocare Brånemark | K | 3.3, 3.75, 4.0, 5.0 | 3.5, 4.1, 4.1, 5.1 | | | Straumann Bone Level | L | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.8 | | | Straumann Standard | N | 3.3, 4.1, 4.8 | 3.5(NNC), 4.8, 6.5 | | | Zimmer Tapered Screw-vent® | R | 3.3, 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 | | | Astra Tech OsseoSpeed™ | S | 3.0, 3.5, 4.0, 4.5, 5.0 | 3.0, 3.5, 4.0, 4.5, 5.0 | | | Dentsply Friadent® Frialit/XiVE® | T | 3.4, 3.8, 4.5, 5.5 | 3.4, 3.8, 4.5, 5.5 | | Medentika PreFace is intended for use with the Straumann® CARES® System. All digitally designed abutments for<br>use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated<br>milling center. | | | | | | Reference Device<br>MegaGen Co., Ltd | Indications for Use | | | | | XPEED AnyRidge<br>Internal Implant<br>System<br>K122231 | The Xpeed AnyRidge Internal Implant System is intended to be surgically placed in the maxillary or mandibular<br>molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures)<br>in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less<br>than Ø6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate<br>occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading. | | | | | MegaGen Co., Ltd<br>AnyOne Internal<br>Implant System<br>K123988 | The AnyOne™ Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar<br>areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in<br>partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less<br>than Ø6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate<br>occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading. | | | | | MegaGen Co., Ltd<br>MiNi Internal<br>Implant System<br>K150537 | The MiNi Internal Implant System is intended for two-stage surgical procedures in the following situations and with<br>the following clinical protocols:<br>- The intended use for the 3.0 mm diameter MiNi implant is limited to the replacement of maxillary lateral incisors<br>and mandibular incisors.<br>- Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.<br>- It is intended for delayed loading. | | | | | MegaGen Co., Ltd<br>AnyRidge<br>Internal System<br>K110955 | The AnyRidge Internal Implant System is intended to be surgically in the maxillary or mandibular molar areas for the<br>purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully<br>edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.00mm) are<br>dedicated for immediate when good primary stability is achieved and with appropriate occlusal loading. Larger implants<br>are dedicated for the molar region and are indicated for delayed loading. | | | | | Dentium Co., Ltd.<br>Dentium<br>Ti-Base | Dentium Ti-Base abutments are intended for use on Dentium endosseous dental implants in the edentulous or partially<br>edentulous maxilla or mandible, as an aid in prosthetic rehabilitation. All digitally designed abutments for use with<br>Dentium Ti-Base abutments are intended to be sent to a Dentium-validated milling center for manufacture. | | | | #### 7.1. Comparison of the Indications for Use {8}------------------------------------------------ | Biomet 3i<br>BellaTek Encode<br>Healing Abutments<br>K173374 | The TSV BellaTek Encode Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration. | |--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Substantial Equivalence Discussion | | ## 1. Similarities The indications for use statement of the subject device has the primary predicate device, K150203, to support prosthetic rehabilitation when used with dental implants in the maxilla or fully edentulous patients. Both the subject device and predicate device are intended for the digitally designed abutments to be manufactured at valiling centers owned by each applicant. ### 2. Differences The indications for use statement of the subject device is nearly identical to the primary predicate, except for minor changes in wording that do not affect the intended use. Different validated milling centers owned by each applicant are also referenced. ### 3. Discussion The differences in the indications for use statement between the subject device and primary predicate device, K150203, are only minor changes in wording and do not affect the intended use for demonstrating substantial equivalence. Based on the information in the submission, it is concluded that the substantially equivalent to the predicate device. {9}------------------------------------------------ # 7.2 Comparison for each component | 7.2.1<br>TiGEN Abutment | | | | | | | |----------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device | Predicate Device | Reference Devices | | | | | 510(k) Number | K220562 | K150203 | K122231 | K123988 | K150537 | K182448 | | Device Name | TIGEN Abutment | Medentika<br>CAD/CAM<br>Abutments | XPEED AnyRidge<br>Internal Implant<br>System | AnyOne Internal<br>Implant System | MiNi Internal Implant<br>System | Ota Abutment For<br>AnyRidge Octa 1<br>Implant System | | Manufacturer | MegaGen Co., Ltd. | Medentika GmbH | MegaGen Co., Ltd. | MegaGen Co., Ltd. | MegaGen Co., Ltd. | MegaGen Co., Ltd. | | Abutment Design | CAD/CAM Blank | CAD/CAM Blank | Multiple Designs | Multiple Designs | Multiple Designs | Multiple Designs | | Restoration | Single-unit,<br>Multi-unit | Single-unit,<br>Multi-unit | Single-unit,<br>Multi-unit | Single-unit,<br>Multi-unit | Single-unit,<br>Multi-unit | Single-unit,<br>Multi-unit | | Abutment Angle | Up to 30° | Up to 30° | 15°, 25° | 15°, 25° | 15° | 0° | | Abutment/<br>Implant<br>Interface | Internal, External | Internal, External | Internal | Internal | Internal | Internal | | Abutment<br>Material | Ti-6Al-4V ELI | Titanium Alloy | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | | Sterilization | Non-sterile; intended<br>for terminal<br>sterilization via<br>autoclave | Non-sterile | Non-sterile; intended<br>for terminal<br>sterilization via<br>autoclave | Non-sterile; intended<br>for terminal<br>sterilization via<br>autoclave | Non-sterile; intended<br>for terminal<br>sterilization via<br>autoclave | Non-sterile; intended<br>for terminal<br>sterilization via<br>autoclave | | Abutment<br>Diameter (mm) | 10, 12 | 3.0~7.0 | 4.0~10.0 | 3.8~10.0 | 3.0~3.5 | 3.8 | | Octa abutment<br>Interface<br>Abutment | TIGEN Abutment<br>(Octa level), is used<br>with Octa Abutment.<br>Image: TIGEN Abutment | Unknown | Gold Cylinder<br>Plastic Cylinder and<br>CCM Cylinder, EZ Post<br>Cylinder are used with<br>Octa Abutment.<br>Image: Gold Cylinder Plastic Cylinder and CCM Cylinder, EZ Post Cylinder are used with Octa Abutment. | Gold Cylinder<br>Plastic Cylinder and<br>CCM Cylinder, EZ Post<br>Cylinder are used with<br>Octa Abutment.<br>Image: Gold Cylinder Plastic Cylinder and CCM Cylinder, EZ Post Cylinder are used with Octa Abutment. | NA | Gold Cylinder<br>Plastic Cylinder and<br>CCM Cylinder, EZ Post<br>Cylinder are used with<br>Octa Abutment.<br>Image: Gold Cylinder Plastic Cylinder and CCM Cylinder, EZ Post Cylinder are used with Octa Abutment. | | Platform<br>Diameter (mm) | -Standard Type<br>: 2.31, 2.8, 3.1, 3.3<br>-Octa Level Type<br>: 3.8, 4.0, 4.8, 5.0,<br>5.8, 6.0 | Unknown | 3.1 | 3.1, 3.3 | 2.31 | 2.8, 3.3 | {10}------------------------------------------------ | Fixture Diameter<br>(mm) | Standard Type | | | | | | | |------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--------------------------------------| | | XPEED<br>AnyRidg e<br>Internal Implant System<br>AnyOne Internal Implant System<br>MiNi Internal Implant System<br>AnyRidg e Octa 1 Implant System | 3.5, 4.0,<br>4.5, 5.0,<br>5.5, 6.0,<br>6.5, 7.0,<br>7.5, 8.0<br>3.5, 4.0,<br>4.5, 5.0,<br>6.0, 7.0,<br>7.5, 8.0<br>3.0,<br>3.25<br>3.6, 3.7,<br>4.0, 4.1,<br>4.4, 4.8,<br>5.0, 5.5 | 3.3~7.0 | Internal type:<br>4.0, 4.4, 4.9, 5.4, 5.9<br>(For normal ridge)<br>6.4, 6.9, 7.4, 7.9, 8.4<br>(For low ridge) | Internal type:<br>3.9, 4.3, 4.8, 5.3, 6.3,<br>7.3<br>(For normal ridge)<br>4.8, 5.8, 6.8, 7.8, 8.3<br>(For deep Thread)<br>4.8, 5.3, 6.3, 7.3<br>(For special length) | Internal Type;<br>3.0, 3.4 | 3.6, 4.0, 4.4, 4.7, 4.8,<br>5.0, 5.5 | | | Octa Level Type<br>XPEED<br>AnyRidg e<br>Internal Implant System<br>AnyOne Internal Implant System<br>AnyRidg e Octa 1 Implant System | 3.5, 4.0,<br>4.5, 5.0,<br>5.5, 6.0,<br>6.5, 7.0,<br>7.5, 8.0<br>3.5, 4.0,<br>4.5, 5.0,<br>6.0, 7.0,<br>7.5, 8.0<br>3.6, 3.7,<br>4.0, 4.1,<br>4.4, 4.8,<br>5.0, 5.5 | | | | | | | Substantial Equivalence Discussion | | | | | | | | #### 1. Similarities The subject device has the same characteristic for the followings compared to the predicate device, K150203. - Indications for use, Abutment Design, Restoration, Abutment/Implant Interface and Abutment Material. The sterilization method is the same as the reference device, K182448. #### 2. Difference The subject device has the different characteristic for the Octa Abutment Interface. - It is unknown if K150203 has not Octa Level Abutment is identical with K122231 and K123988 that they are fastened on Octa Abutment. #### 3. Discussion The subject device and primary predicate device are cylindrich with precision implant / abutment interface for use in fabricating a patientspecific abutment at a manufacturer-validated milling center. The subject device and predicate device have common as following the storation, Abutment Angle, Abutment/Implant Interface. Abutment Material and Abutment angle. For the Abutnent angle of subject devices, the worst assems of yoe and Octa Level Type and faligue tests were performed to confirm the substantial equivalence in accordance with 'SO 14801 ' and 'Cass II Special Controls Guidance Document: Root form Endosseous Dental Implants and Endosseous Dental Implant Abutnent'. The test result subject device is substantially equivalent to the predicate device and the difference is not affecting the substantial equivalence. The subject device and reference device, K122231 and K123988, have common as following: Octa Abutment Interface. The subject device is supplied in nor-sterilization validating testing for steam sterilization by the user has been performed in accordance with ISO 11137 and ISO 1765-1, 2 to verify the sterility assurance lization validation of non-sterile subject device can be leverged with reference device which was evaluated under the previous 510(k) submission. K182448. Based on the information based in submission, it is concluded that the substantially equivalent to the predicate device. {11}------------------------------------------------ #### ZrGEN Abutment 7.2.2 | 7.2.2 ZrGEN Abutment | | | | | | | | | |-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-----------------------------------|--|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| | | Subject Device | | Predicate Device | | Reference Devices | | | | | 510(k) Number | K220562 | | K150203 | | K171622 | K122231 | K123988 | K150537 | | Device Name | ZrGEN Abutment | | Medentika<br>CAD/CAM<br>Abutments | | Dentium Ti-Base | XPEED AnyRidge<br>Internal Implant<br>System | AnyOne Internal<br>Implant System | MiNi Internal<br>Implant<br>System | | Manufacturer | MegaGen Co., Ltd. | | Medentika GmbH | | Dentium Co.,<br>Ltd. | MegaGen Co., Ltd. | MegaGen Co., Ltd. | MegaGen Co.,<br>Ltd. | | Abutment<br>Design | TiBase | | TiBase | | TiBase | Multiple Designs | Multiple Designs | Multiple<br>Designs | | Restoration | Single-unit,<br>Multi-unit | | Single-unit,<br>Multi-unit | | Single-unit,<br>Multi-unit | Single-unit,<br>Multi-unit | Single-unit,<br>Multi-unit | Single-unit,<br>Multi-unit | | Abutment<br>Angle | 0° | | Up to 30° | | Up to 30° | 15°, 25° | 15°, 25° | 15° | | Prosthesis<br>Attachment | Cement-retained<br>Screw-retationed | | Cement-retained | | Cement-<br>retained<br>Screw-<br>retationed | Cement-retained<br>Screw-retationed | Cement-retained<br>Screw-retationed | Cement-<br>retained<br>Screw-<br>retationed | | Abutment/<br>Implant<br>Interface | Internal, External…