BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇦🇺 Australia

    THE ORTHOTRAINER

    K Number: K924975 · Decision Jul 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    112
    Registration Numbers
    112
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    281

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    Basic Information

    Device Name
    THE ORTHOTRAINER
    K Number
    K924975
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5525
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Myofunctional Research Corp. Pty. , Ltd.
    Date Received
    September 30, 1992
    Decision Date
    July 8, 1993
    Product Code
    KMY
    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
    KMY Positioner, Tooth, Preformed

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