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510(k) Data Aggregation

    K Number
    K014082
    Device Name
    D.SIGN 53, MODEL NA1012204
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2002-01-30

    (50 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    d.SIGN 53 alloy intended to be used for onlays, % crowns, telescope crowns, conus crowns, posts, short and long span bridges, PFM crowns.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental alloy, d.SIGN 53. It does not contain any information about acceptance criteria, study details, device performance metrics, sample sizes, ground truth establishment, or expert involvement as requested.

    Therefore, I cannot fulfill your request for the specific information regarding a study and its results from the given text.

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