FDA 510(k) Application Details - K153411

Device Classification Name	Handpiece, Air-Powered, Dental   More FDA Info for this Device
510(K) Number	K153411
Device Name	Handpiece, Air-Powered, Dental
Applicant	DENTALEZ, INC. 1816 COLONIAL VILLAGE LANE LANCASTER, PA 17601 US Other 510(k) Applications for this Company
Contact	DAN LASKOWITZ 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	11/25/2015
Decision Date	04/08/2016
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