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510(k) Data Aggregation

    K Number
    K972955
    Device Name
    PALCERAM 56
    Manufacturer
    AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD
    Date Cleared
    1997-09-05

    (77 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PALCERAM 56

    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

    Palladium silver based casting alloy

    AI/ML Overview

    Here's an analysis of the provided text regarding the Palceram 56 dental casting alloy, addressing your request for acceptance criteria and study details.

    Important Note: The provided document is a 510(k) summary for a medical device seeking market clearance in the US. For such devices, often the "study" proving acceptance criteria is a comparison to a legally marketed predicate device demonstrating substantial equivalence, rather than a standalone clinical trial in the way a pharmaceutical might have. This document primarily focuses on demonstrating that the new device is as safe and effective as an existing one through comparison of material properties.

    Acceptance Criteria and Reported Device Performance

    1. Table of Acceptance Criteria and Reported Device Performance:

    The "acceptance criteria" here are implicitly linked to the properties of the legally marketed predicate device, "Aurium Aurolite IK." The new device, "Palceram 56," is considered acceptable if its properties are comparable or within acceptable ranges relative to the predicate. The document doesn't explicitly state numerical acceptance thresholds for each property, but rather presents a side-by-side comparison to demonstrate similarity.

    Property/TestAcceptance Criteria (Implicitly from Aurium Aurolite IK)Reported Palceram 56 PerformanceOutcome (Comparison)
    Composition (weight%)
    Ag~30%32%Similar
    Pd~58%56.5%Similar
    Sn~6%3.9%Reasonably similar (minor difference)
    In~4%7.3%Reasonably similar (minor difference)
    Zn
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