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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
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    GESTENCO INTERNATIONAL AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding an Orthodontic Polymer Composite Bracket. It primarily addresses regulatory approval based on substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided document.

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