FDA 510(k) Application Details - K161077

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K161077
Device Name	Agent, Tooth Bonding, Resin
Applicant	Apex Dental Materials, Inc 330 Telser Road Lake Zurich, IL 60047 US Other 510(k) Applications for this Company
Contact	Scott Lamerand Other 510(k) Applications for this Contact
Regulation Number	872.3200   More FDA Info for this Regulation Number
Classification Product Code	KLE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/18/2016
Decision Date	03/17/2017
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