The following data is part of a premarket notification filed by Nobel Biocare Services Ag with the FDA for Nobelprocera Zirconia N1 Base.
| Device ID | K220048 |
| 510k Number | K220048 |
| Device Name: | NobelProcera Zirconia N1 Base |
| 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 | 2022-01-06 |
| Decision Date | 2022-07-29 |