The following data is part of a premarket notification filed by Megagen Implant Co., Ltd. with the FDA for Healing Abutment, Cover Screw.
| Device ID | K210826 |
| 510k Number | K210826 |
| Device Name: | Healing Abutment, Cover Screw |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil Daegu, KR 42921 |
| Contact | You Jung Kim |
| Correspondent | Hyo Eun Lee DaeGyeong Regulatory Affairs Institute 32, Innovalley-ro Daegu, KR 41065 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-19 |
| Decision Date | 2022-02-03 |