LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K052462
    Device Name
    G-COAT
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2005-10-20

    (42 days)

    Product Code
    EBD
    Regulation Number
    872.3310
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    G-COAT

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

    To seal the surface of direct composite and glass-ionomer restorations, indirect composite restorations, provisional restorations and their adhesive interface of margin to enamel or dentin.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, study details, or device performance metrics for the G-Coat device. The given text is primarily a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to legally marketed devices and can be marketed. It does not contain the detailed technical or clinical study data that would include acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case study results.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1