FDA 510(k) Application Details - K972683

Device Classification Name Alloy, Other Noble Metal

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510(K) Number K972683
Device Name Alloy, Other 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 EJS
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Date Received 07/17/1997
Decision Date 08/18/1997
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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