W&H Dentalwerk Buermoss GmbH FDA Approvals

0 new drug approvals and 2 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
Proxeo ULTRA (PB-510, PB-520 and PB-530)510(k)Jul 14, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 14, 2023
AMADEO, M-UK1015 (incl. attachments and accessories)510(k)May 26, 2022Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	May 26, 2022