The following data is part of a premarket notification filed by Noris Medical Ltd with the FDA for Noris Medical Dental Implants System.
| Device ID | K210356 |
| 510k Number | K210356 |
| Device Name: | Noris Medical Dental Implants System |
| Classification | Abutment, Implant, Dental, Endosseous |
| 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 | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-08 |
| Decision Date | 2022-02-04 |