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510(k) Data Aggregation

    K Number
    K011661
    Device Name
    CONCORD 88
    Manufacturer
    GATEWAY ALLOYS, INC.
    Date Cleared
    2001-08-27

    (90 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Type
    Abbreviated
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CONCORD 88 (PM-43) is a yellow colored gold/platinum dental casting alloy for restorations subject to high stress and that require porcelain enamels be fused to some of the surfaces. It may also be used as a Type III (hard) crown and bridge alloy. It is intended for use in the manufacture of single units, ¾ crowns, and short-span bridgework.

    Device Description

    CONCORD 88 (PM-43) is a yellow colored gold/platinum dental casting alloy.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA for a dental casting alloy named "Concord 88." This document is not a study report for an AI/ML powered medical device, but rather a regulatory approval for a material.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set information cannot be extracted from this document, as it pertains to a different type of medical device approval.

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