FDA 510(k) Application Details - K052463

Device Classification Name	Alloy, Gold-Based Noble Metal   More FDA Info for this Device
510(K) Number	K052463
Device Name	Alloy, Gold-Based Noble Metal
Applicant	PROMETAL TECHNOLOGIES 67 MAIN STREET SILVER CREEK, NY 14136 US Other 510(k) Applications for this Company
Contact	DONNA MARIE HARTNETT 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	09/08/2005
Decision Date	10/14/2005
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