FDA 510(k) Application Details - K141422

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K141422
Device Name	Varnish, Cavity
Applicant	PAC-DENT INTERNATIONAL, INC. 21038 Commerce Pointe Dr. Walnut, CA 91789 US Other 510(k) Applications for this Company
Contact	WENYING ZHU 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	05/30/2014
Decision Date	09/30/2014
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