FDA 510(k) Application Details - K243280

Device Classification Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece   More FDA Info for this Device
510(K) Number	K243280
Device Name	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Applicant	W&H Dentalwerk Buermoos GmbH Ignaz-Glaser-Stra▀e 53 Buermoos 5111 AT Other 510(k) Applications for this Company
Contact	Gerhard Weidler 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	10/17/2024
Decision Date	07/03/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review