FDA 510(k) Application Details - K172543

Device Classification Name	Handpiece, Air-Powered, Dental   More FDA Info for this Device
510(K) Number	K172543
Device Name	Handpiece, Air-Powered, Dental
Applicant	Beijing Dongbo Dental Handpiece Co., Ltd. Room 201, Building 4, No.9 Anqing Street Area B of Tianzhu Airport Industrial Beijing 101318 CN Other 510(k) Applications for this Company
Contact	Chengfei Yan 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	08/23/2017
Decision Date	07/11/2018
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