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510(k) Data Aggregation

    K Number
    K221000
    Device Name
    ON3D
    Manufacturer
    Date Cleared
    2022-05-23

    (49 days)

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

    3D ONS, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ON3D is software that is designed for use by specialized dental practices for capturing, storing and presenting patient images and assisting in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed dental practitioners.
    Device Description
    ON3D is a stand-alone software that captures, stores and present patient data in volumetric views to assist specialized dental practitioners for treatment and surgical planning and case diagnosis. With a user-friendly graphical user interface, ON3D makes processing 3D data extremely simple, enabling dental specialists from a wide variety of disciplines to diagnose, plan treatment, document and present cases. ON3D allows visualization and analysis of craniofacial anatomy from data produced by 3D dataset format, such as cone beam computed tomography (CBCT), and it creates a personalized 3D model for the dentists with the optimal pre-surgical information necessary for the surgeries. It features tools for the manipulation and analysis of volumetric datasets, and the images are easily oriented and rotated. Tissue density thresholds can be adjusted for detailed views of craniofacial anatomy. ON3D product features include 3D airway analysis, multiple planar views, volume stitching, 2D/3D facial photo wrap onto the volumetric model, 3D neural canal markings, TMJ analysis, 3D/2D measurements, export images to other applications, such as STL or PLY, and more.
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