The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobelprocera Zirconia Implant Bridge.
Device ID | K202452 |
510k Number | K202452 |
Device Name: | NobelProcera Zirconia Implant Bridge |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | Nobel Biocare AB Vastra Hamngatan 1 Goteborg Gotlands Lan, SE 411 17 |
Contact | Bernice Jim |
Correspondent | Bernice Jim Nobel Biocare AB Vastra Hamngatan 1 Goteborg Gotlands Lan, SE 411 17 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-08-27 |
Decision Date | 2020-12-03 |