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510(k) Data Aggregation

    K Number
    K984427
    Device Name
    EXCELSIOR PORCELAIN SYSTEM
    Manufacturer
    NEY DENTAL, INC.
    Date Cleared
    1999-03-15

    (94 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    FOR USE IN THE MANUFACTURE OF METAL-CERAMIC RESTORATIONS.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the Excelsior Porcelain System. It does not contain any information regarding acceptance criteria, device performance metrics, study design, sample sizes, ground truth establishment, or expert qualifications for a medical device study.

    Therefore, I cannot fulfill your request using the provided information. The text is purely a regulatory approval document and lacks the technical details of a performance study.

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