W&H Dentalwerk Bürmoos 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
Angled Screwdriver MED (M-SD090)510(k)Jul 31, 2026Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 31, 2026
Synea Fusion Handpieces (Intensiv & Profin)510(k)Feb 28, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	Feb 28, 2025