FDA 510(k) Application Details - K082768

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K082768
Device Name	Agent, Tooth Bonding, 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	872.3200   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	09/22/2008
Decision Date	10/21/2008
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