BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    NITOM LOCKING FACEBOW

    K Number: K052553 · Decision Dec 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    35
    Applicant Total
    1
    Review Days
    97

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    Basic Information

    Device Name
    NITOM LOCKING FACEBOW
    K Number
    K052553
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5500
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Russell Samuels Orthodontic Design
    Date Received
    September 16, 2005
    Decision Date
    December 22, 2005
    Product Code
    DZB
    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
    DZB Headgear, Extraoral, Orthodontic

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