FDA 510(k) Application Details - K132123

Device Classification Name	Resin, Root Canal Filling   More FDA Info for this Device
510(K) Number	K132123
Device Name	Resin, Root Canal Filling
Applicant	KM CORPORATION 1515 E KATELLA AVE UNIT 2115 ANAHEIM, CA 92805 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	07/10/2013
Decision Date	03/20/2014
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