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 |