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510(k) Data Aggregation

    K Number
    K053055
    Device Name
    ORTHODONTIC POLYMER COMPOSITE BRACKET
    Manufacturer
    GESTENCO INTERNATIONAL AB
    Date Cleared
    2005-12-22

    (52 days)

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

    GESTENCO INTERNATIONAL AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orthodontic Polymer Composite Bracket is intended to be bonded on teeth to aid in the movement of patient's teeth during orthodontic treatment.
    Device Description
    Orthodontic Polymer Composite Bracket
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