The following data is part of a premarket notification filed by Nobel Biocare Ag with the FDA for Nobel Biocare Dental Implant Systems Portfolio - Mr Conditional.
| Device ID | K212125 |
| 510k Number | K212125 |
| Device Name: | Nobel Biocare Dental Implant Systems Portfolio - MR Conditional |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Nobel Biocare AG P.O. Box, 8058 Zurich - Airport Balsberg, Balz Zimmermann-str. 7, CH 8302 |
| Contact | Bernice Jim |
| Correspondent | Bernice Jim Nobel Biocare AG P.O. Box, 8058 Zurich - Airport Balsberg, Balz Zimmermann-str. 7, CH 8302 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-07 |
| Decision Date | 2021-09-24 |