FDA 510(k) Application Details - K980660

Device Classification Name	Alloy, Gold-Based Noble Metal   More FDA Info for this Device
510(K) Number	K980660
Device Name	Alloy, Gold-Based Noble Metal
Applicant	EUROPEAN DENTAL IMPORTS, INC. 49 EMERSON RD. DURHAM, NH 03824-2112 US Other 510(k) Applications for this Company
Contact	GISELA N EVERNGAM 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	02/20/1998
Decision Date	04/27/1998
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