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510(k) Data Aggregation

    K Number
    K192244
    Device Name
    Arcad SmileStudio and Aligner System
    Manufacturer
    ArcadLab
    Date Cleared
    2020-05-11

    (266 days)

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

    ArcadLab

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arcad SmileStudio 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 Arcad Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Arcad Aligner System positions teeth by way of continuous gentle force. The use of the Arcad SmileStudio and Aligner System requires 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
    The Arcad SmileStudio software is an orthodontic diagnosis and treatment simulation software for use by dental professionals. SmileStudio imports patient 3-D digital scans and allows the user to diagnose 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 sequential aligner trays or retainers. The Arcad Aligner System is a series of customized clear plastic removable aligners that are fabricated from a clear. thin thermoformed polyurethane. The aligners are designed to gradually move the patient's teeth incrementally, repositioning them from their original misalignment to a more aligned state. ArcadLab manufactures the customized aligners based on either standard impressions or intraoral scans sent to the company by the prescribing dentist or orthodontist. Arcadlab manufactures models from the impressions and those models are scanned using standard validated software. The digital files are used to produce the aligner series with the thermoplastic polyurethane. The packaged aligners are sent to the dental clinician who then distributes them in sequential stages to the patient and follows up with the patient through orthodontic examinations to check device fit and function. The thermoplastic material used for fabrication of the aligners is commonly used in many dental appliances, including the predicate aligners.
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