The following data is part of a premarket notification filed by Noris Medical Ltd with the FDA for Noris Medical Dental Implants System - Cortical.
| Device ID | K210852 |
| 510k Number | K210852 |
| Device Name: | Noris Medical Dental Implants System - Cortical |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Noris Medical Ltd 8 Hataasia Nesher, IL 3688808 |
| Contact | Simha Sibony |
| Correspondent | Simha Sibony Noris Medical Ltd 8 Hataasia Nesher, IL 3688808 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-22 |
| Decision Date | 2022-06-24 |