FDA 510(k) Application Details - K212178

Device Classification Name	Locator, Root Apex   More FDA Info for this Device
510(K) Number	K212178
Device Name	Locator, Root Apex
Applicant	Foshan COXO Medical Instrument Co., Ltd. BLDG 4, District A, Guangdong New Light Source Industrial Base, South of Luocun Avenue, Nanhai District Foshan 528226 CN Other 510(k) Applications for this Company
Contact	Yongjian Zheng Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2021
Decision Date	07/20/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review