FDA 510(k) Application Details - K080724

Device Classification Name	Adhesive, Bracket And Tooth Conditioner, Resin   More FDA Info for this Device
510(K) Number	K080724
Device Name	Adhesive, Bracket And Tooth Conditioner, Resin
Applicant	GC AMERICA, INC. 3737 WEST 127TH ST. 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	03/14/2008
Decision Date	06/11/2008
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