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510(k) Data Aggregation

    K Number
    K212828
    Device Name
    BRIUS Planner Software
    Manufacturer
    BRIUS Technologies Inc
    Date Cleared
    2021-10-01

    (28 days)

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

    BRIUS Technologies Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BRIUS Planner 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, Sequential Aligners, 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 treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of the BRIUS Planner 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 Planner Software is an orthodontic appliance design and treatment simulation software. This software is used as a manufacturing software for orthodontic appliances. It is also used 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 dental appliances using standard stereolithographic (STL) for the design of custom shape-set nitinol appliances or clear aligners.
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