FDA 510(k) Application Details - K120176

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K120176
Device Name	Varnish, Cavity
Applicant	CENTRIX, INC. 11234 EL CAMINO REAL STE 200 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	LINDA K SCHULZ Other 510(k) Applications for this Contact
Regulation Number	872.3260   More FDA Info for this Regulation Number
Classification Product Code	LBH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/20/2012
Decision Date	07/25/2012
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