FDA 510(k) Application Details - K083036

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K083036
Device Name	Varnish, Cavity
Applicant	VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 CUXHAVEN D-27472 DE Other 510(k) Applications for this Company
Contact	M. PLAUMANN 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	10/14/2008
Decision Date	01/12/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review