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510(k) Data Aggregation

    K Number
    K981036
    Device Name
    SMARTBOND
    Manufacturer
    GAC INTL., INC.
    Date Cleared
    1999-04-05

    (382 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K020648
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    the bonding Adhesive to be used as an orthodontic bonding agent, for the bonding of orthodontic braces on the tooth (brackets, tubes and which ever) for a limited period of time.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) clearance letter for a device called "Smart-Bond," an orthodontic bonding agent. The provided text is a regulatory document and does not contain information about acceptance criteria, device performance studies, or technical details about the device's efficacy or safety. Therefore, I cannot generate the requested table and study details.

    The document only states that the device is substantially equivalent to a legally marketed predicate device, allowing it to proceed to market. It does not include performance data or clinical trial results.

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