FDA 510(k) Applications Submitted by MEGAGEN IMPLANT CO., LTD.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K123870 |
12/17/2012 |
XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM |
MEGAGEN IMPLANT CO., LTD. |
| K242030 |
07/11/2024 |
MegaGen Dental Implant Abutment |
MegaGen Implant Co., Ltd. |
| K223339 |
11/01/2022 |
Bone Chamber Implant |
MegaGen Implant Co., Ltd. |
| K190096 |
01/22/2019 |
R2GATE |
MegaGen Implant Co., Ltd. |
| K230618 |
03/06/2023 |
MegaGen Dental Implant Systems Portfolio - MR Conditional |
MegaGen Implant Co., Ltd. |
| K182448 |
09/07/2018 |
AnyRidge Octa 1 Implant System |
MegaGen Implant Co., Ltd. |
| K211812 |
06/11/2021 |
BLUEDIAMOND IMPLANT, Abutment Screw |
MegaGen Implant Co., Ltd. |
| K220562 |
02/28/2022 |
TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment |
MegaGen Implant Co., Ltd. |
| K234142 |
12/29/2023 |
TiGEN Abutment, PMMA Abutment and Scan Healing Abutment |
MegaGen Implant Co., Ltd. |
| K211556 |
05/19/2021 |
N2 |
MegaGen Implant Co., Ltd. |
| K191127 |
04/29/2019 |
Advanced Intermezzo Implant System |
MegaGen Implant Co., Ltd. |
| K231967 |
07/03/2023 |
ARi ExCon Implant System |
MegaGen Implant Co., Ltd. |
| K240754 |
03/20/2024 |
N2 |
MegaGen Implant Co., Ltd. |
| K233450 |
10/20/2023 |
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 |
MegaGen Implant Co., Ltd. |
| K222219 |
07/25/2022 |
R2 Studio Q/RCT820 |
MegaGen Implant CO., Ltd. |
| K203554 |
12/04/2020 |
AnyOne External Implant System |
MegaGen Implant Co., Ltd. |
| K210161 |
01/21/2021 |
AnyOne Onestage Implant System |
MegaGen Implant Co., Ltd. |
| K210826 |
03/19/2021 |
Healing Abutment, Cover Screw |
MegaGen Implant Co., Ltd. |
| K192614 |
09/23/2019 |
Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment |
MegaGen Implant CO., Ltd. |
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