FDA 510(k) Application Details - K232717

Device Classification Name	Locator, Root Apex   More FDA Info for this Device
510(K) Number	K232717
Device Name	Locator, Root Apex
Applicant	Changzhou Haili Medical Co., Ltd. Hutang Science Technology Industrial Park, Wujin District Changzhou 213000 CN Other 510(k) Applications for this Company
Contact	Wang Xiaofang 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	09/05/2023
Decision Date	12/22/2023
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