W&H Dentalwerk Buermoos GmbH FDA Approvals

0 new drug approvals and 3 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
Implantmed Plus II & Piezomed Plus II Module510(k)Jun 18, 2026Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jun 18, 2026
Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)510(k)Jul 3, 2025Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Jul 3, 2025
PROXEO Twist Cordless Polishing System PL-40 H510(k)Feb 24, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Feb 24, 2021