FDA 510(k) Application Details - K242179

Device Classification Name	Handpiece, Air-Powered, Dental   More FDA Info for this Device
510(K) Number	K242179
Device Name	Handpiece, Air-Powered, Dental
Applicant	W&H Dentalwerk Bⁿrmoos GmbH Ignaz-Glaser-Stra▀e 53 Bⁿrmoos 5111 AT Other 510(k) Applications for this Company
Contact	Gerhard Weidler Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EFB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2024
Decision Date	02/28/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review