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510(k) Data Aggregation

    K Number
    K212770
    Device Name
    Vision
    Manufacturer
    SoftSmile, Inc.
    Date Cleared
    2021-12-21

    (112 days)

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

    SoftSmile, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SoftSmile Vision 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 design of a series of dental casts, which may be used for sequential aligner trays or retainers, 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 SoftSmile Vision requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.
    Device Description
    SoftSmile Vision is orthodontic planning and treatment simulation software for use by dental professionals. SoftSmile Vision imports patient 3-D digital scans and allows the user to plan the orthodontic treatment needs of the patient and develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate by a manufacturer sequential aligner trays or retainers.
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