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510(k) Data Aggregation

    K Number
    K192202
    Device Name
    Clear21
    Manufacturer
    World Class Technology Corporation
    Date Cleared
    2019-11-12

    (90 days)

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

    World Class Technology Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Clear21™ orthodontic ceramic bracket system is intended to aid in the movement of teeth during orthodontic treatment.
    Device Description
    The Clear21™ orthodontic ceramic bracket system from World Class Technology Corporation is a system of aesthetic passive self-ligating brackets for fixed appliance orthodontic treatment. The brackets are bonded directly to patient's teeth of the maxillary arch. The self-ligating mechanism (i.e. the door) eliminates the need for elastomeric and steel ligatures. The system is intended for use with clinician chosen orthodontic auxiliary devices.
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