The following data is part of a premarket notification filed by Cybermed Inc. with the FDA for Core1 Implant System.
Device ID | K210039 |
510k Number | K210039 |
Device Name: | CORE1 Implant System |
Classification | Implant, Endosseous, Root-form |
Applicant | Cybermed Inc. 6-26, Yuseong-daero 1205 Beon-gil Yuseong-gu, KR 34104 |
Contact | Han Seul Kim |
Correspondent | Cheol Young Kim Cybermed Inc. 6-26, Yuseong-daero 1205 Beon-gil Yuseong-gu, KR 34104 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-01-06 |
Decision Date | 2022-01-07 |