The following data is part of a premarket notification filed by Nobel Biocare Ag with the FDA for Universal Base Conical Connection (cc).
Device ID | K200040 |
510k Number | K200040 |
Device Name: | Universal Base Conical Connection (CC) |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | Nobel Biocare AG Balz Zimmermann-Strasse 7 Kloten Zurich, CH 8302 |
Contact | Bernice Jim |
Correspondent | Bernice Jim Nobel Biocare AG Balz Zimmermann-Strasse 7 Kloten Zurich, 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 | 2020-01-08 |
Decision Date | 2020-03-30 |
Summary: | summary |