Dürr Dental SE FDA Approvals

0 new drug approvals and 6 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
Hygienic Protective Bite Cover (2207-010-50)510(k)Sep 17, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Sep 17, 2026
VistaSoft 4.0 and VisionX 4.0510(k)Aug 27, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 27, 2025
Provecta 3D Prime and Provecta 3D Prime Ceph510(k)Sep 14, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Sep 14, 2023
ScanX Swift 2.0, ScanX Swift View 2.0510(k)Feb 6, 2023Dental	Dental	510(k)Substantially Equivalent (Special)	Feb 6, 2023
VisionX 3.0510(k)Nov 2, 2021Radiology	Radiology	510(k)Substantially Equivalent (Special)	Nov 2, 2021
SensorX510(k)Mar 19, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Mar 19, 2021