The following data is part of a premarket notification filed by Surgikor Llc with the FDA for Surgikor Dental Implant System.
| Device ID | K182615 |
| 510k Number | K182615 |
| Device Name: | Surgikor Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Surgikor LLC 1299 W Jefferson Blvd Los Angeles, CA 90007 |
| Contact | Jeremy Barbanell |
| Correspondent | Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030 -0172 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-21 |
| Decision Date | 2019-07-08 |