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510(k) Data Aggregation

    K Number
    K013997

    Validate with FDA (Live)

    Device Name
    UNIFIL BOND
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2002-02-20

    (78 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Unifil Bond is a light-cured dentin bonding system to provide effective bonding to resin composite restorative materials.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification for a dental bonding agent, Unifil Bond, submitted to the FDA in 2001. The document is a regulatory approval letter and does not contain information about acceptance criteria or performance studies of the device.

    Therefore, I cannot extract the requested information from the provided text. The document confirms the device is substantially equivalent to legally marketed predicate devices, but it does not detail any specific studies, acceptance criteria, or performance metrics.

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