FDA 510(k) Application Details - K122708

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K122708
Device Name	Varnish, Cavity
Applicant	SYLPHAR N.V. PIAZZA ALBANIA 10 ROME, ITALY 00153 IT Other 510(k) Applications for this Company
Contact	ROGER GRAY 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	09/04/2012
Decision Date	01/14/2013
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