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510(k) Data Aggregation

    K Number
    K191720
    Device Name
    BRUIS Software Suite
    Manufacturer
    Mechanodontics, Inc.
    Date Cleared
    2020-04-17

    (295 days)

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

    Mechanodontics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BRIUS Software Suite is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, treatment simulation and virtual appliance design options (Patient-Specific Nitinol Wires, Export of Models, Indirect Bonding Transfer Media) 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 BRIUS Software Suite 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 BRIUS Software Suite is an orthodontic appliance design and treatment simulation software. Until recently, this software was used only as a manufacturing software for nitinol wires, indirect bonding transfer media, and export of models. This software is now for use by professional technicians or physicians to design solutions for patients. Digital scans (3D) of a patient denture can be loaded into the software and a technician or physician can then create treatment plans for each individual patient and their needs. After approval by the patient's physician, the system can be used to fabricate patient-specific nitinol wires, indirect bonding transfer media, and export of models using standard stereolithographic (STL) and drawing exchange format (DXF) files for the design of custom shape-set nitinol wires. A 2D rendering of the nitinol wires needed for the patient can be created in the form of a DXF file and a 3D representation of the ideal tooth alignment for the patient can be created in the form of an STL file. The 2D rendering can then be used to laser cut a nitinol sheet to form a 2D version of the patient-specific nitinol wire shape. Finally, a high-temperature mold can be fabricated from the STL file to shape set the 2D cut nitinol wire for a specific fit for patients.
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