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510(k) Data Aggregation

    K Number
    K993344
    Device Name
    P10 SPECIAL
    Manufacturer
    NORTH AMERICAN ALLOYS, INC.
    Date Cleared
    1999-11-15

    (41 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTH AMERICAN ALLOYS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For the fabrication of a custom crown or bridge prosthesis by a dental laboratory. It is to be offered as an alternative to nickel-based crown and bridge alloys for nickel sensitive patients, as well as for international markets which prefer cobalt-based alloys.
    Device Description
    P10 Special alloy is a cobalt based crown and bridge alloy containing chromium and molybdenum.
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