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

    STERNGOLD BIO-4

    K Number: K962304 · Decision Jul 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    193
    Applicant Total
    16
    Review Days
    36

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    Basic Information

    Device Name
    STERNGOLD BIO-4
    K Number
    K962304
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3060
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sterngold/Implamed
    Date Received
    June 17, 1996
    Decision Date
    July 23, 1996
    Product Code
    EJS
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EJS Alloy, Other Noble Metal

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    Other Clearances by Sterngold/Implamed

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    K962326 STERNGOLD BIO-5 (1127210)
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