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510(k) Data Aggregation

    K Number
    K993572
    Device Name
    CERADIUM V NON-PRECIOUS CERAMIC ALLOY
    Manufacturer
    MATECH, INC.
    Date Cleared
    1999-12-13

    (53 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 Amixture of Nickel and Chromium
    • Intended Use: This material is to be used by the dentist in the fabrication of Ba custom-made dental device, such as a porcelain veneer for a tooth.
    • Classifcation: Class II C-
    Device Description

    Ceradium V Non-Precious Ceramic Alloy

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental alloy, Ceradium V Non-Precious Ceramic Alloy. This document does not contain any information about acceptance criteria or a study proving device performance. It only states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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