FDA 510(k) Application Details - K102575

Device Classification Name	Resin, Root Canal Filling   More FDA Info for this Device
510(K) Number	K102575
Device Name	Resin, Root Canal Filling
Applicant	DO CO., LTD. 2341 W. CRESCENT AVE #3 ANAHEIM, CA 92801 US Other 510(k) Applications for this Company
Contact	Priscilla Chung 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	09/08/2010
Decision Date	10/29/2010
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