Nobel Biocare Services AG FDA Approvals

0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
NobelZygoma PureSet Tray510(k)Jun 27, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jun 27, 2023
Esthetic Abutments Nobel Biocare N1510(k)Sep 16, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Sep 16, 2022
NobelProcera Zirconia N1 Base510(k)Jul 29, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 29, 2022
N1 TiUltra TCC Implant System510(k)Dec 21, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Dec 21, 2021
Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray510(k)Dec 18, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Dec 18, 2021