Megagen Implant Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 32
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251232 | MegaGen Zygoma Dental Implant System | June 18, 2026 |
| K242030 | MegaGen Dental Implant Abutment | January 13, 2025 |
| K241972 | BLUEDIAMOND IMPLANT | December 27, 2024 |
| K234142 | TiGEN Abutment, PMMA Abutment and Scan Healing Abutment | September 18, 2024 |
| K240754 | N2 | March 21, 2024 |
| K233450 | MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Com | January 22, 2024 |
| K231967 | ARi ExCon Implant System | December 7, 2023 |
| K223909 | R2GATE Lite TM | October 20, 2023 |
| K230618 | MegaGen Dental Implant Systems Portfolio - MR Conditional | October 11, 2023 |
| K223339 | Bone Chamber Implant | July 18, 2023 |
| K211556 | N2 | April 5, 2023 |
| K211812 | BLUEDIAMOND IMPLANT, Abutment Screw | January 6, 2023 |
| K222219 | R2 Studio Q/RCT820 | December 6, 2022 |
| K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment | November 10, 2022 |
| K210826 | Healing Abutment, Cover Screw | February 3, 2022 |
| K203808 | Multi-unit Abutment, Multi-unit Angled Abutment | October 20, 2021 |
| K203554 | AnyOne External Implant System | August 28, 2021 |
| K210161 | AnyOne Onestage Implant System | June 22, 2021 |
| K192614 | Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment | February 13, 2020 |
| K192347 | ST Internal Implant System | November 14, 2019 |