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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
    Why did this record match?
    Device Name :

    HIPALLAUR 19

    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
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