FDA 510(k) Application Details - K964578

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K964578
Device Name	Material, Tooth Shade, Resin
Applicant	JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 WALLINGFORD, CT 06492-0724 US Other 510(k) Applications for this Company
Contact	MURRAY G GAMBERG 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	11/15/1996
Decision Date	12/03/1996
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