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510(k) Data Aggregation

    K Number
    K082768
    Device Name
    G-BOND PLUS
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2008-10-21

    (29 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    G-BOND PLUS

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

    G-BOND PLUS is one-bottle typed light-cured bonding agent, and intended to be used for bonding light-cured composite resin to tooth.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a dental bonding agent named "G-BOND PLUS." This document focuses on the regulatory authorization for marketing the device based on its substantial equivalence to a predicate device. It does not contain information regarding acceptance criteria for a specific performance study, the device's reported performance against such criteria, or details of a study that would demonstrate such performance (e.g., sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies with AI).

    Therefore, I cannot answer your request based on the provided text. This document is a regulatory approval notice, not a scientific study report.

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