FDA 510(k) Application Details - K092912

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K092912
Device Name	Material, Tooth Shade, Resin
Applicant	DANVILLE MATERIALS, INC. 3420 FOSTORIA WAY, SUITE A-200 SAN RAMON, CA 94583 US Other 510(k) Applications for this Company
Contact	LINDSAY TILTON 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	09/22/2009
Decision Date	12/16/2009
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