Nobel Biocare AB FDA Approvals

0 new drug approvals and 10 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
LiteSet Trays510(k)Sep 8, 2026General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Sep 8, 2026
Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw510(k)Aug 6, 2026Dental	Dental	510(k)Substantially Equivalent (Traditional)	Aug 6, 2026
Nobel Biocare S Series Implants510(k)Feb 18, 2026Dental	Dental	510(k)Substantially Equivalent (Traditional)	Feb 18, 2026
NobelZygoma TiUltra Implant system510(k)Aug 25, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	Aug 25, 2025
NobelProcera Zirconia Implant Bridge510(k)Jan 3, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jan 3, 2025
NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium510(k)Jan 24, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jan 24, 2024
DTX Studio Clinic (4.0)510(k)Dec 8, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 8, 2023
Titanium Abutment Blank Nobel Biocare N1 TCC510(k)Apr 28, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Apr 28, 2023
DTX Studio Clinic 3.0510(k)Mar 28, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 28, 2023
DTX Studio Clinic 3.0510(k)Mar 25, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 25, 2022