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510(k) Data Aggregation

    K Number
    K043493
    Device Name
    FUSION PUTTY TYPE
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2005-03-04

    (77 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This product is a high consistency vinylpolysiloxane impression material to be used for taking intra-oral impressions.

    Device Description

    Not Found

    AI/ML Overview

    The document provided is a 510(k) premarket notification letter from the FDA for a device called "FUSION PUTTY," an impression material. It determines substantial equivalence to a predicate device but does not contain information about acceptance criteria, device performance, or a study that proves the device meets specific criteria.

    Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study from the provided document. The document is essentially an approval letter based on equivalence, not a performance study report.

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