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510(k) Data Aggregation

    K Number
    K971575
    Device Name
    BENCHMARK-IV
    Manufacturer
    J.F. JELENKO & CO., INC.
    Date Cleared
    1997-06-04

    (58 days)

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

    It is palladium free, rich gold colored, Type-IV extra hard alloy for Hard Inlays, Crowns, Fixed Bridgework. This High noble alloy offers strength, resilency and hardness for hard inlays and longspan bridges. It resists tarnish and discoloration and can be quenched (Soft ) and heat-treated ( Hardened ).It can be used for restorative works.

    Device Description

    Benchmark- IV is a palladium free, rich gold colored, Type-IV extra hard alloy.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental alloy named "Benchmark-IV." It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/medical device study.

    Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies based on the provided text. The document is a regulatory approval notice, not a study report.

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