LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K972941
    Device Name
    AURECAST 74
    Manufacturer
    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD
    Date Cleared
    1997-08-28

    (69 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

    Dental casting alloy for making restoration.

    Device Description

    High gold casting alloy

    AI/ML Overview

    The provided document is a 510(k) summary for a dental casting alloy, AURECAST 74. It describes the device, its intended use, and a comparison to a legally marketed predicate device (Jelenko Modulay). This document does not describe a study involving an AI/ML device or its acceptance criteria, performance, or validation methods.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, or MRMC studies for an AI/ML device from this text. The provided text is purely a regulatory submission for a traditional medical device (dental alloy).

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1