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510(k) Data Aggregation

    K Number
    K221475
    Device Name
    MyClearALIGN Dental Aligner System
    Date Cleared
    2022-08-31

    (103 days)

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

    Key Dental Technologies, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MyClearALIGN Dental Aligner System is indicated for the alignment of all permanent teeth/full permanent dentition during orthodontic treatment of malocclusions by way of continuous gentle forces.
    Device Description
    MyClearALIGN Dental Aligner System device is a clear aligner system fabricated using the commercially available Zendura FLX, a clear, thin thermoformed Copolyester – Polyurethane Composite with 2 outer layers of cycloaliphatic polyester and an inner layer of polyether polyurethane. The pressure areas create forces that combine to form couples and thus a moment around or near the center of resistance or center of rotation of the tooth. A series of aligners is fabricated to sequentially move the teeth from their original positions of better alignment. Each set of aligners is designed to be replaced after approximately 2 weeks of 20-22 hours of wear per day (Approximately 300 hours per aligner). Each tooth is moved no greater than 0.25mm in one aligner stage (approximately 2 weeks of 20-22 hours of wear per day).
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