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510(k) Data Aggregation

    K Number
    K142729
    Device Name
    Chi Lites Orthodontic Sapphire Bracket
    Date Cleared
    2015-05-15

    (234 days)

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

    PROGRESSIVE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Progressive Technology Inc. Chi Lites Orthodontic Sapphire Bracket is a line of single-use devices intended for orthodontic movement of teeth. The bracket is used temporarily and is removed upon completion of orthodontic treatment.
    Device Description
    Progressive Technology Inc. is submitting this Premarket Notification for its Class II product, an orthodontic sapphire bracket. The device is intended for use in conjunction with comprehensive orthodontics to control the movement of individual teeth. The brackets are comprised of several geometries that vary from bracket to bracket, corresponding to the intended tooth. These geometries contribute to the fit of the bracket to the tooth and also impart the axial control of the energy from the archwire.
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