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510(k) Data Aggregation

    K Number
    K022430
    Device Name
    ISO FUNCTIONAL
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2002-10-18

    (85 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K110378
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ISO Functional is used as a rebasing and relining impression material.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a dental impression material. This document does not contain information about acceptance criteria, study details, or performance metrics for a device regarding AI/ML.

    Therefore, I cannot extract the requested information about acceptance criteria, study details, sample sizes, ground truth, or multi-reader multi-case studies because that information is not present in the provided text.

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