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FDA 510(k) Application Details - K993508
Device Classification Name
Alloy, Gold-Based Noble Metal
More FDA Info for this Device
510(K) Number
K993508
Device Name
Alloy, Gold-Based Noble Metal
Applicant
METALOR DENTAL USA CORP.
255 JOHN L. DIETSCH BLVD.
NORTH ATTLEBOROUGH, MA 02761 US
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Contact
KENNETH A PUTNEY
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Regulation Number
872.3060
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Classification Product Code
EJT
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More FDA Info for this Product Code
Date Received
10/15/1999
Decision Date
12/06/1999
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
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