The following data is part of a premarket notification filed by Nobel Biocare Services Ag with the FDA for Esthetic Abutments Nobel Biocare N1.
| Device ID | K220339 |
| 510k Number | K220339 |
| Device Name: | Esthetic Abutments Nobel Biocare N1 |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Nobel Biocare Services AG Balz Zimmermann-Str. 7 Kloten, CH 8302 |
| Contact | Bernice Jim |
| Correspondent | Bernice Jim Nobel Biocare Services AG Balz Zimmermann-Str. 7 Kloten, CH 8302 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-07 |
| Decision Date | 2022-09-16 |