FDA 510(k) Application Details - K002854

Device Classification Name	Alloy, Gold-Based Noble Metal   More FDA Info for this Device
510(K) Number	K002854
Device Name	Alloy, Gold-Based Noble Metal
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	ANNMARIE TENERO Other 510(k) Applications for this Contact
Regulation Number	872.3060   More FDA Info for this Regulation Number
Classification Product Code	EJT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/11/2000
Decision Date	12/20/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review