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510(k) Data Aggregation

    K Number
    K220140
    Device Name
    ClearCorrect System
    Manufacturer
    Date Cleared
    2022-10-05

    (260 days)

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

    ClearCorrect, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ClearCorrect System is indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion.
    Device Description
    The aligners of the ClearCorrect System are a sequential series of clear thermoformed orthodontic appliances that, when worn in the prescribed sequence and duration, progressively reposition the teeth. The aligner is an orthodontic appliance intended for intra-oral use. Individual devices will be used between 20 – 22 hours per day for a period ranging from one to three weeks. The corrective forces to align teeth are primarily generated by the difference between the starting tooth position and the planned tooth position defined by the appliance. Features can be added to the aligner that engage with composite resin tooth attachments to improve aligner retention and/or to apply forces in directions that cannot be achieved by engaging with tooth surfaces alone.
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