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510(k) Data Aggregation

    K Number
    K993013
    Device Name
    SURE BOND
    Manufacturer
    MIRADENT DISTRIBUTING CO., LLC.
    Date Cleared
    1999-11-29

    (83 days)

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

    This device/method is a means of conditioning enamel and dentin to Obtain adhesive bonding of polymeric materials. It is used by dental professionals in restorative procedures.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a dental product named "Sure Bond." This document does not contain any information about acceptance criteria, study details, or device performance metrics.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria, as the necessary information is absent from the provided text.

    The document only states that:

    • The device is substantially equivalent to a legally marketed predicate device.
    • The device's intended use is "a means of conditioning enamel and dentin to obtain adhesive bonding of polymeric materials. It is used by dental professionals in restorative procedures."
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