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510(k) Data Aggregation

    K Number
    K032318
    Device Name
    MINERVA 58 ALLOY
    Manufacturer
    DENTSPLY INTERNATIONAL
    Date Cleared
    2003-09-30

    (64 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K951782
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MINERVA 58 ALLOY is indicated as a dental alloy for fabricating MOD inlays, crowns, bridges, precision milling bars and attachments, and partial dentures.

    Device Description

    MINERVA 58 ALLOY is a high noble, gold-based dental alloy.

    AI/ML Overview

    The provided document is a 510(k) summary for a dental alloy, MINERVA 58 ALLOY, and not an AI/ML device. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable to this document. The document primarily focuses on demonstrating substantial equivalence to a predicate device based on material composition and prior marketing history in Europe.

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