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510(k) Data Aggregation

    K Number
    K251124
    Device Name
    G-Bond Universal
    Manufacturer
    GC America, Inc.
    Date Cleared
    2025-10-02

    (174 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K192961,K143140,K100062
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K192961

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. Direct bonding of restorative materials
    2. Bonding of dual-cured core build up composites
    3. Adhesive cementation of indirect restorations
    4. Priming of adherent surface of indirect restorations
    5. Intraoral repair of fractured restorations
    6. Treatment of hypersensitive teeth
    7. Sealing of tooth preparation (cavity or abutment) for indirect restorations
    8. Treatment of exposed root surfaces
    9. Micro-invasive treatment and infiltration of non-cavitated non-carious enamel lesions
    10. Post cementation
    Device Description

    G-BOND Universal is a one component, light-cured bonding agent, which can also be used for micro-invasive treatment and infiltration of non-cavitated non-carious enamel lesions, available in a 5 mL liquid bottle or 0.1 mL unit dose.

    AI/ML Overview

    N/A

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