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510(k) Data Aggregation

    K Number
    K022224
    Device Name
    COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM
    Manufacturer
    COLTENE AG
    Date Cleared
    2002-09-18

    (70 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For the cementation/affixing of metal and/or ceramic orthodontic brackets to teeth.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the "Cool Bond Light Cured Bracket Adhesive System." It does not contain information about acceptance criteria or a study proving the device meets those criteria.

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

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