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510(k) Data Aggregation

    K Number
    K972950
    Device Name
    HIPALLAUR 19
    Manufacturer
    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD
    Date Cleared
    1997-09-05

    (77 days)

    Product Code
    EJT,DAT
    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 used in combination with dental ceramics for fabrication of metallo-ceramic restoration.

    Device Description

    Gold reduced palladium based casting alloy

    AI/ML Overview

    The provided document is a 510(k) summary for a dental casting alloy, Hipallaur 19. It focuses on demonstrating substantial equivalence to a predicate device (Aurolite 2A) through a comparison of composition and physical/mechanical properties. This type of submission is not a clinical study report and therefore does not contain the information requested in your prompt regarding acceptance criteria, study design, expert ground truth, or human-AI performance.

    The document discusses the technical characteristics of the device and its predicate, including:

    • Comparison of composition (weight %):

      • Legal (Aurolite 2A): Au (13.5), Ag (27.8), Pd (49.5), Sn (4.6), In (4.4), Fe (0), Mn (0), Ru (x < 1%)
      • New (Hipallaur 19): Au (19), Ag (10.4), Pd (57.1), Sn (10.3), In (2.3), Fe (0.3), Mn (0.5), Ru (0.1)

    • Comparison of physical and mechanical properties:

    ALLOYPropertyAurolite 2AHipallaur 19
    Melting point (solid.)1270°C1210°C
    Melting point (liquid)1335°C1250°C
    Hardness (Vickers 5/30)170 (soft)270 (hard)
    370 (hard)
    Yield strength (MPa)462 (soft)640 (hard)
    670
    Elongation (%)8 (soft)20 (hard)
    Density (g/cm³)14.613.7
    • Test Methods Applied: ANSI/ADA 5 and ISO 9693 standards were used for testing the characteristics.

    The report concludes that the new alloy (Hipallaur 19) is very similar to Aurolite 2A based on its constitution, with potentially slightly better corrosion resistance due to higher noble metal content.

    In summary, the document does not contain the information you requested about acceptance criteria and a study proving device performance in a clinical or AI context because it is a regulatory submission for a dental casting alloy, not a clinical trial or AI performance study.

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