FDA 510(k) Application Details - K021805

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K021805
Device Name	Varnish, Cavity
Applicant	DENTSPLY INTL. 570 WEST COLLEGE AVE. YORK, PA 17405-0872 US Other 510(k) Applications for this Company
Contact	P. JEFFERY LEHN 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	06/03/2002
Decision Date	08/19/2002
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