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 |