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510(k) Data Aggregation

    K Number
    K992881
    Device Name
    HI BOND NON-PRECIOUS CERAMIC ALLOY
    Manufacturer
    MATECH, INC.
    Date Cleared
    1999-11-19

    (85 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Identification: A base metal alloy is a device composed of a material such as a mixture of Nickel and Chromium
    • Intended Use: This material is to be used by the dentist in the fabrication of a custom-made dental device, such as a porcelain veneer for a tooth.
    • Classification: Class II
    Device Description

    Hi Bond Non-Precious Ceramic Alloy is a base metal alloy composed of a material such as a mixture of Nickel and Chromium.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a dental alloy, specifically "Hi Bond Non-Precious Ceramic Alloy." This document does not contain any information about acceptance criteria, device performance studies, or clinical trial data.

    The letter is a regulatory document confirming that the device is "substantially equivalent" to devices already on the market, which is a different concept than providing evidence of performance through a study described in the prompt's request.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence, not on specific performance metrics or studies as outlined in your prompt.

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