FDA 510(k) Application Details - K013400

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K013400
Device Name	Material, Tooth Shade, Resin
Applicant	COLTENE/WHALEDENT INC. 750 CORPORATE DR. MAHWAH, NJ 07430-2009 US Other 510(k) Applications for this Company
Contact	H.J. VOGELSTEIN 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	10/15/2001
Decision Date	12/10/2001
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