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510(k) Data Aggregation

    K Number
    K231396
    Device Name
    CEPHX- Cephalometric Analysis Software
    Manufacturer
    Date Cleared
    2024-01-31

    (261 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Orca Dental AI LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CEPHX - Cephalometric Analysis Software is indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO (Visual Treatment Objective), and patient consultation. Results produced by the software's diagnosic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists. The device is only for use on patients 14 years old and above.
    Device Description
    CEPHX – Cephalometric Analysis Software uses cephalometric x-ray images to help dentists study the relationships between bone and soft tissue landmarks and can be used to diagnose facial abnormalities throughout an orthodontic treatment. As a first step, the user uploads a 2D cephalometric image and the software generates 99 cephalometric landmark points. The landmarks are important points in a lateral radiographic view of the teeth, jaws and base of the skull, and are used in multiple cephalometric analyses, which have proven to be a useful aid in basic orthodontic differential diagnosis. Once the landmark points are created, the user can generate a full report by choosing from a large selection of built-in analysis methods or create a customed analysis using the Analysis Wizard. The report can be printed or downloaded according to the user selection.
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