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510(k) Data Aggregation

    K Number
    K190394
    Device Name
    SunClear Aligner system
    Date Cleared
    2019-12-16

    (300 days)

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

    Sun Dental Laboratories, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SunClear Aligner system is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). SunClear Aligners positions teeth by way of continuous gentle force.
    Device Description
    SunClear Aligners consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3-D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state. SunClear Aligners are intended as an alternative to conventional bracket technology and fixed appliances for the treatment of patients with malocclusion. The proprietary software generates the final image of a treated state and then interpolates a series of images that represent the intermediate teeth states. The dental practitioner then reviews these images to depict, edit, view, monitor, and approve an orthodontic treatment plan.
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