FDA 510(k) Application Details - K082740

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K082740
Device Name	Powder, Porcelain
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	872.6660   More FDA Info for this Regulation Number
Classification Product Code	EIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/2008
Decision Date	11/26/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review