FDA 510(k) Application Details - K070190

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K070190
Device Name	Material, Tooth Shade, Resin
Applicant	GC AMERICA INC. 3737 WEST 127TH STREET ALSIP, IL 60803 US Other 510(k) Applications for this Company
Contact	TERRY L JORITZ-LYONS 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	01/22/2007
Decision Date	03/12/2007
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