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

    UNITEK LIFT-OFF DEBRACKETING INSTRUMENT

    K Number: K854088 · Decision Nov 26, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    50

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    Basic Information

    Device Name
    UNITEK LIFT-OFF DEBRACKETING INSTRUMENT
    K Number
    K854088
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Unitex Corp.
    Date Received
    October 7, 1985
    Decision Date
    November 26, 1985
    Product Code
    JEX
    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
    JEX Plier, Orthodontic

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