FDA 510(k) Application Details - K112168

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K112168
Device Name	Material, Tooth Shade, Resin
Applicant	COLTENE/WHALEDENT AG 235 ASCOT PARKWAY CUYAHOGA FALLS, OH 44223 US Other 510(k) Applications for this Company
Contact	MARK VAN METER 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	07/28/2011
Decision Date	11/21/2011
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