Megagen Implant Co., Ltd.
FDA 510(k) & PMA Approved Devices — 23 products
Total Devices23
Categories5
Latest FDA decision2026-06-18
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K251232 | MegaGen Zygoma Dental Implant System | DZE | 2026-06-18 | View |
| 510(k) | K242030 | MegaGen Dental Implant Abutment | NHA | 2025-01-13 | View |
| 510(k) | K241972 | BLUEDIAMOND IMPLANT | DZE | 2024-12-27 | View |
| 510(k) | K234142 | TiGEN Abutment, PMMA Abutment and Scan Healing Abutment | NHA | 2024-09-18 | View |
| 510(k) | K240754 | N2 | EIA | 2024-03-21 | View |
| 510(k) | K233450 | MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw | NHA | 2024-01-22 | View |
| 510(k) | K231967 | ARi ExCon Implant System | DZE | 2023-12-07 | View |
| 510(k) | K223909 | R2GATE Lite TM | LLZ | 2023-10-20 | View |
| 510(k) | K230618 | MegaGen Dental Implant Systems Portfolio - MR Conditional | DZE | 2023-10-11 | View |
| 510(k) | K223339 | Bone Chamber Implant | DZE | 2023-07-18 | View |
| 510(k) | K211556 | N2 | EIA | 2023-04-05 | View |
| 510(k) | K211812 | BLUEDIAMOND IMPLANT, Abutment Screw | DZE | 2023-01-06 | View |
| 510(k) | K222219 | R2 Studio Q/RCT820 | OAS | 2022-12-06 | View |
| 510(k) | K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment | NHA | 2022-11-10 | View |
| 510(k) | K210826 | Healing Abutment, Cover Screw | NHA | 2022-02-03 | View |
| 510(k) | K203808 | Multi-unit Abutment, Multi-unit Angled Abutment | NHA | 2021-10-20 | View |
| 510(k) | K203554 | AnyOne External Implant System | DZE | 2021-08-28 | View |
| 510(k) | K210161 | AnyOne Onestage Implant System | DZE | 2021-06-22 | View |
| 510(k) | K192614 | Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment | NHA | 2020-02-13 | View |
| 510(k) | K192347 | ST Internal Implant System | DZE | 2019-11-14 | View |
No matching devices.
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