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 |