FDA 510(k) Application Details - K150128

Device Classification Name	Adhesive, Bracket And Tooth Conditioner, Resin   More FDA Info for this Device
510(K) Number	K150128
Device Name	Adhesive, Bracket And Tooth Conditioner, Resin
Applicant	GC Orthodontics America Inc. 11535 S.Central Avenue Alsip, IL 60803 US Other 510(k) Applications for this Company
Contact	Mark Heiss 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	01/20/2015
Decision Date	07/16/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review