FDA 510(k) Application Details - K082171

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K082171
Device Name	Material, Tooth Shade, Resin
Applicant	GC AMERICA, INC 3737 W. 127TH STREET ALSIP, IL 60803 US Other 510(k) Applications for this Company
Contact	MARK HEISS Other 510(k) Applications for this Contact
Regulation Number	872.3690   More FDA Info for this Regulation Number
Classification Product Code	EBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2008
Decision Date	10/30/2008
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