FDA 510(k) Application Details - K962405

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K962405
Device Name	Material, Tooth Shade, Resin
Applicant	EFOS CANADA, INC. 2260 ARGENTIA RD. MISSISSAUGA, ONTARIO L5N 6H7 CA Other 510(k) Applications for this Company
Contact	EDWARD SMITH 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	06/21/1996
Decision Date	08/29/1996
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