FDA 510(k) Application Details - K151274

Device Classification Name	Locator, Root Apex   More FDA Info for this Device
510(K) Number	K151274
Device Name	Locator, Root Apex
Applicant	GOOD DOCTORS CO., LTD. #208, Woolim Lions Valley B-dong, 283 Bupyeong-daero Bupyeong-gu Incheon 403-911 KR Other 510(k) Applications for this Company
Contact	Sungro Joo 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	05/13/2015
Decision Date	02/04/2016
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