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

    REMOLDABLE CRANIOMANDIBULAR APPLIANCE

    K Number: K833455 · Decision Jan 10, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    112
    Registration Numbers
    112
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    105

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    Basic Information

    Device Name
    REMOLDABLE CRANIOMANDIBULAR APPLIANCE
    K Number
    K833455
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5525
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Jeffrey H. Attlin
    Date Received
    September 27, 1983
    Decision Date
    January 10, 1984
    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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