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    K Number
    K201036
    Device Name
    PlaniMax Orthodontic Software
    Manufacturer
    Choice Biotech Inc.
    Date Cleared
    2020-12-22

    (246 days)

    Product Code
    PNN
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Choice Biotech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PlaniMax Orthodontic Software is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. These applications are based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of the PlaniMax requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
    Device Description
    The PlaniMax Orthodontic Software for dental retainers and dental cast for sequential aligners is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models , virtual planning of orthodontic treatments by simulating tooth movements , and design of orthodontic appliances based on 3D scanned orthodontic models.
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