BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ISOSTATIC CONDENSER

    K Number: K843901 · Decision Dec 3, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    2
    Applicant Total
    59
    Review Days
    61

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    Basic Information

    Device Name
    ISOSTATIC CONDENSER
    K Number
    K843901
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Shofu Dental Corp.
    Date Received
    October 3, 1984
    Decision Date
    December 3, 1984
    Product Code
    EKG
    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
    EKG Condenser, Amalgam And Foil, Operative

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