FDA 510(k) Application Details - K052263

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K052263
Device Name	Varnish, Cavity
Applicant	COSMEDENT, INC. 401 NORTH MICHIGAN AVE. SUITE 2500 CHICAGO, IL 60611 US Other 510(k) Applications for this Company
Contact	JAMES L SANDRIK 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	08/19/2005
Decision Date	12/16/2005
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