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510(k) Data Aggregation

    K Number
    K082434
    Device Name
    GDLS-200
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2008-11-14

    (81 days)

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

    GDLS-200

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

    GDLS is a light-cured micro-filled radiopaque composite resin for the restoration of both anterior and posterior teeth. GDLS-200 consists of two delivery systems, Unitip (capsules for single dose) and Syringes. The GDLS-20() systems is available in a variety of shades.

    Device Description

    GDLS-200 is a light-cured micro-filled radiopaque composite resin for the restoration of both anterior and posterior teeth. GDLS-200 consists of two delivery systems, Unitip (capsules for single dose) and Syringes. The GDLS-20() systems is available in a variety of shades.

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a dental device (GDLS-200) and an "Indications for Use" statement. It does NOT contain information about acceptance criteria, study details, or device performance metrics as requested in the prompt.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document only confirms that the FDA found the device substantially equivalent to a predicate device for its indicated uses.

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