FDA 510(k) Application Details - K242765

Device Classification Name	Locator, Root Apex   More FDA Info for this Device
510(K) Number	K242765
Device Name	Locator, Root Apex
Applicant	Shenzhen Superline Technology Co., Ltd. Room 302, Nanshan Zhiyuan A4, No.1001 Xueyuan Avenue, Changyuan Community, Taoyuan Street, Nanshan District Shenzhen 518000 CN Other 510(k) Applications for this Company
Contact	Jinsong Zhou 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	09/13/2024
Decision Date	01/17/2025
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