BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    STARCAST DENTAL ALLOYS

    K Number: K031543 · Decision May 30, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    626
    Applicant Total
    2
    Review Days
    14

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    Basic Information

    Device Name
    STARCAST DENTAL ALLOYS
    K Number
    K031543
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3060
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Star Refining Precious Metals South Africa
    Date Received
    May 16, 2003
    Decision Date
    May 30, 2003
    Product Code
    EJT
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EJT Alloy, Gold-Based Noble Metal

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    Other Clearances by Star Refining Precious Metals South Africa

    K Number Device Name
    K032106 STARBOND DENTAL BONDING ALLOYS