FDA 510(k) Application Details - K994435

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K994435
Device Name	OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS
Applicant	JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 WALLINGFORD, CT 06492 0724 Other 510(k) Applications for this Company   More Company Info and Competitors
Contact	ANNMARIE TENERO Other 510(k) Applications for this Contact
Regulation Number	872.6660   More FDA Info for this Regulation Number
Classification Product Code	EIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/1999
Decision Date	02/10/2000
Decision	SE - Substantially Equivalent
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review	N