FDA 510(k) Application Details - K050486

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K050486
Device Name	Varnish, Cavity
Applicant	SUNSTAR BUTLER 70 W. MADISON ST., SUITE 3300 CHICAGO, IL 60602 US Other 510(k) Applications for this Company
Contact	RICHARD O WOOD 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	02/25/2005
Decision Date	06/07/2005
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