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510(k) Data Aggregation

    K Number
    K041398
    Device Name
    GC FUSION
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2004-06-25

    (30 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GC FUSION

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

    The Product is a dental vinylpolysiloxane impression material intended for use of taking intra-oral impressions of a patient's mouth.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information needed to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a dental impression material named "GC FUSION."

    While it confirms the device is substantially equivalent to legally marketed predicate devices, it does not include any specific performance specifications, acceptance criteria, or details about the studies conducted to demonstrate those criteria.

    The document primarily focuses on:

    • The FDA's determination of substantial equivalence.
    • Regulatory information (regulation number, name, class, product code).
    • General controls and compliance requirements for the manufacturer.
    • The intended use of the device.

    To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a detailed product submission that outlines the performance characteristics and the data supporting them.

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