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510(k) Data Aggregation

    K Number
    K032289
    Device Name
    FIT CHECKER II
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2003-10-20

    (88 days)

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

    FIT CHECKER II

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

    Silicone fit examining material used to detect high spots and pressure points of crowns, bridges, veneers, inlays and dentures.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a Letter of Substantial Equivalence from the FDA for a device named "FIT CHECKER II." This document does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or study designs (such as MRMC or standalone studies).

    It is a regulatory approval letter based on the device's substantial equivalence to a legally marketed predicate device, rather than a detailed study report demonstrating performance against specific acceptance criteria.

    Therefore, I cannot provide the requested information from the given text.

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