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    K Number
    K153048
    Device Name
    AcceleDent Aura
    Manufacturer
    ORTHOACCEL TECHNOLOGIES, INC.
    Date Cleared
    2016-07-08

    (263 days)

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

    ORTHOACCEL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AcceleDent® Aura is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.
    Device Description
    The AcceleDent® Aura is an orthodontic accessory for the treatment of tooth malocclusion. AcceleDent® Aura should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment.
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