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510(k) Data Aggregation

    K Number
    K050750
    Device Name
    LC BRACKET ADHESIVE SYSTEM
    Manufacturer
    DENTSPLY INTL.
    Date Cleared
    2005-04-06

    (14 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K033703
    Why did this record match?
    Device Name :

    LC BRACKET ADHESIVE SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Bonding of orthodontic brackets to natural and artificial tooth surfaces

    Device Description

    The LC BRACKET ADHESIVE SYSTEM is a two-part lightcure system (adhesive and primer) used in conjunction with a tooth conditioner.

    AI/ML Overview

    The provided text is a 510(k) summary for the DENTSPLY International LC BRACKET ADHESIVE SYSTEM. It describes the device, its intended use, and states that it relies on substantial equivalence to predicate devices because its components have been used in legally marketed devices.

    However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt. It is a regulatory filing stating substantial equivalence, not a study report.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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