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510(k) Data Aggregation

    K Number
    K070840
    Device Name
    GVC-100
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2007-05-15

    (49 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    GVC-100 is a radiopaque light-cured resin-based luting cement for porcelain (or composite) laminate veneer or inlay restoration.

    Device Description

    GVC-100 is a radiopaque light-cured resin-based luting cement

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental cement product named "GVC-100." It does not contain any information about acceptance criteria, device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods), or any information regarding AI, multi-reader multi-case studies, or standalone algorithm performance.

    Therefore, I cannot provide the requested information based on the given input. The document is strictly a regulatory clearance notice and does not include scientific study results or performance data.

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