FDA 510(k) Application Details - K080228

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K080228
Device Name	Varnish, Cavity
Applicant	NOVAMIN TECHNOLOGY, INC. 13859 PROGRESS BLVD.,#600 ALACHUA, FL 32615 US Other 510(k) Applications for this Company
Contact	ROBERT G ROTHFRITZ 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	01/30/2008
Decision Date	03/27/2008
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