FDA 510(k) Application Details - K201993

Device Classification Name	Handpiece, Direct Drive, Ac-Powered   More FDA Info for this Device
510(K) Number	K201993
Device Name	Handpiece, Direct Drive, Ac-Powered
Applicant	Changzhou Sifary Medical Technology Co., Ltd. No. 99, Qingyang Road, Xuejia County, Xinbei District Changzhou City 213000 CN Other 510(k) Applications for this Company
Contact	Amanda Zhu 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	07/17/2020
Decision Date	01/29/2021
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