FDA 510(k) Application Details - K982458

Device Classification Name	Alloy, Amalgam   More FDA Info for this Device
510(K) Number	K982458
Device Name	Alloy, Amalgam
Applicant	AB ARDENT 54 RIVERVIEW AVE. TONAWANDA, NY 14150-5260 US Other 510(k) Applications for this Company
Contact	CLYDE E INGERSOLL Other 510(k) Applications for this Contact
Regulation Number	872.3070   More FDA Info for this Regulation Number
Classification Product Code	EJJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/1998
Decision Date	08/24/1998
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