FDA 510(k) Application Details - K170261

Device Classification Name	Handpiece, Air-Powered, Dental   More FDA Info for this Device
510(K) Number	K170261
Device Name	Handpiece, Air-Powered, Dental
Applicant	PREMIUM PLUS INTERNATIONAL LIMITED FLAT 1001 YUEN LONG TRADING CENTRE, 33 WANG YIP STREET WEST YUEN LONG, N.T. HONG KONG CN Other 510(k) Applications for this Company
Contact	JESSICA MAO 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	01/27/2017
Decision Date	10/19/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review