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

    SUPERLON (UNILON) CARBOXYLATE CEMENT

    K Number: K861685 · Decision May 19, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    2
    Review Days
    17

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    Basic Information

    Device Name
    SUPERLON (UNILON) CARBOXYLATE CEMENT
    K Number
    K861685
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Carlisle Laboratories, Inc.
    Date Received
    May 2, 1986
    Decision Date
    May 19, 1986
    Product Code
    EMA
    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
    EMA Cement, Dental

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    Other Clearances by Carlisle Laboratories, Inc.

    K Number Device Name
    K861934 SALIVA EJECTOR