FDA 510(k) Application Details - K213221

Device Classification Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece   More FDA Info for this Device
510(K) Number	K213221
Device Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Applicant	W&H Dentalwerk Buermoss GmbH Ignaz-Glaser-Strasse 53 Buermoos 5111 AT Other 510(k) Applications for this Company
Contact	Weidler Gerhard Other 510(k) Applications for this Contact
Regulation Number	874.4250   More FDA Info for this Regulation Number
Classification Product Code	ERL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2021
Decision Date	05/26/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review