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510(k) Data Aggregation

    K Number
    K232429
    Device Name
    Titan Dental Design
    Manufacturer
    ClearAdvance, LLC
    Date Cleared
    2023-10-13

    (63 days)

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

    ClearAdvance, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Titan Dental Design is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media, Sequential aligners) 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 Titan Dental Design 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
    Titan Dental Design by ClearAdvance, LLC is an orthodontic appliance design and treatment planning software. This software is for use by dentists, orthodontists, and trained health care professionals to diagnose and design treatment solutions for patients. The Titan Dental Design software allows users to upload digital scans of patient's dentition to the system, manipulate and move teeth in the dentition scan to create treatment plans for malocclusion, and export or send treatment planning files for physical production of orthodontic appliances such as thermoplastic aligners with the use of 3D printers.
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