FDA 510(k) Application Details - K212983

Device Classification Name	Resin, Root Canal Filling   More FDA Info for this Device
510(K) Number	K212983
Device Name	Resin, Root Canal Filling
Applicant	Beijing C-Root Dental Medical Devices Co., LTD. Room 301, Building 10, Yard 12, Middle Juyuan Road, Mapo Town,Shunyi District Beijing 101300 CN Other 510(k) Applications for this Company
Contact	Bingmin Wu Other 510(k) Applications for this Contact
Regulation Number	872.3820   More FDA Info for this Regulation Number
Classification Product Code	KIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/2021
Decision Date	12/08/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review