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510(k) Data Aggregation

    K Number
    K033808
    Device Name
    GRADIA GUM
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2004-02-02

    (56 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GRADIA GUM

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

    GRADIA GUM is a light-cured composite resin specifically used for the reproduction of the gum on crown and bridge prostheses.

    Device Description

    GRADIA GUM is a light-cured composite resin.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental device called GRADIA GUM. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information from this document.

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