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 |