FDA 510(k) Application Details - K132109

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K132109
Device Name	Varnish, Cavity
Applicant	ULTRADENT PRODUCTS INC. / ORATECH LLC 810 N 2200 W Salt Lake City, UT 84116 US Other 510(k) Applications for this Company
Contact	KAREN KAKUNES 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	07/08/2013
Decision Date	11/01/2013
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