FDA 510(k) Application Details - K191276

Device Classification Name	Handpiece, Direct Drive, Ac-Powered   More FDA Info for this Device
510(K) Number	K191276
Device Name	Handpiece, Direct Drive, Ac-Powered
Applicant	ChangZhou BoMedent Medical Technology Co., Ltd. No.9 Changyang Road, West Taihu Science and Technology Industrial Park ChangZhou 213000 CN Other 510(k) Applications for this Company
Contact	Chen YuLong Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2019
Decision Date	06/30/2020
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