FDA 510(k) Application Details - K203836

Device Classification Name	Locator, Root Apex   More FDA Info for this Device
510(K) Number	K203836
Device Name	Locator, Root Apex
Applicant	ChangZhou BoMedent Medical Technology Co., Ltd No.9 Changyang Road, West Taihu Science & Technology Industrial Park, Changzhou 213100 CN Other 510(k) Applications for this Company
Contact	Zhang Lili 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	12/30/2020
Decision Date	03/30/2021
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