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510(k) Data Aggregation

    K Number
    K233616
    Device Name
    Clevaligner Software (V1.0.0)
    Manufacturer
    Clevaligner Ltd
    Date Cleared
    2024-01-11

    (59 days)

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

    Clevaligner Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clevaligner software is intended for use as a medical device standalone software, 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 Clevaligner Software 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
    Clevaligner Software imports patient 3-D digital scans and provides the orthodontic treatment planning of the patient under dental professional supervision. The Clevaligner Software performs the automatic segmentation of the 3-D digital scans, achieves an automatic design of an ideal arch form, which is approved by orthodontists using a 2D software interface. The Clevaligner Software provides an initial to ideal final stage treatment plan, with each step of the treatment plan path presented in the 3D software interface. Every 3D digital model from the path treatment plan, generated by the Clevaligner Software, can be exported for fabrication of orthodontic appliances, either to an orthodontic laboratory or directly to orthodontic appliance manufacturers for further use in orthodontic treatment.
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