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510(k) Data Aggregation

    K Number
    K171674
    Device Name
    Angel Align System
    Manufacturer
    Smile Development Corp
    Date Cleared
    2018-01-19

    (227 days)

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

    Smile Development Corp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Angel Align System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
    Device Description
    The Angel Align System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state. The Angel Align System is intended as an alternative to conventional wire/bracket technology and fixed appliances for the treatment of patients with malocclusion. The 3D software generates the model of a provisional treated state and then creates a series of models that represent intermediate teeth states. The dental practitioner reviews these models to view, edit or approve the orthodontic treatment plan. The dental practitioner has the option to reject or request modifications to the set-up prior to approving it for aligner fabrication. Once the doctor approves the set-up, the series of custom-made aligners are manufactured, packaged, and shipped to the dental practitioner to be dispensed to the patient for treatment.
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