FDA 510(k) Application Details - K113401

Device Classification Name	Adhesive, Bracket And Tooth Conditioner, Resin   More FDA Info for this Device
510(K) Number	K113401
Device Name	Adhesive, Bracket And Tooth Conditioner, Resin
Applicant	BISCO, INC. 1100 WEST IRVING PARK RD. SCHAUMBURG, IL 60193 US Other 510(k) Applications for this Company
Contact	Michelle Schiltz-Taing Other 510(k) Applications for this Contact
Regulation Number	872.3750   More FDA Info for this Regulation Number
Classification Product Code	DYH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/17/2011
Decision Date	02/07/2012
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