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510(k) Data Aggregation

    K Number
    K082207
    Device Name
    ORTHOCAD IQ
    Manufacturer
    CADENT, INC.
    Date Cleared
    2009-10-23

    (444 days)

    Product Code
    DYW, EJF, NJM
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    CADENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OrthoCAD iQ is a computer-guided system intended for use as an aid in orthodontic treatment planning for use by dental professionals trained in orthodontic treatment including radiographic analyses and treatment planning. OrthoCAD iQ is intended for use with commercially-available brackets and wires that apply continuous gentle force to reposition the teeth. It also uses indirect bonding trays to affix the brackets in position.
    Device Description
    The device consists of the following components and accessories: proprietary software that calculates the position of dental brackets based on the dental impressions and treatment plan supplied by the patient's orthodontist, commercially-available metal, plastic, or ceramic brackets supplied by the orthodontist for that patient, a camera wand with a light curing feature, and customized indirect bonding trays containing the brackets, which are in a hard plastic case. The device does not include the adhesive that affixes the brackets to the teeth or the wires that are used with the brackets to form braces.
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