FDA 510(k) Application Details - K112946

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K112946
Device Name	Varnish, Cavity
Applicant	PULPDENT CORPORATION 80 OAKLAND ST. P.O. BOX 780 WATERTOWN, MA 02471-0780 US Other 510(k) Applications for this Company
Contact	KENNETH J BERK 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	10/04/2011
Decision Date	12/09/2011
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