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 |