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510(k) Data Aggregation

    K Number
    K022811
    Device Name
    W-5
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2002-10-09

    (47 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K003571
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    W-5 alloy intended to be used for onlay, ¾ crows, telescope crowns, conus crowns, posts, short and long span bridges, PFM crowns.

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a dental alloy, W-5. It is a letter from the FDA to Ivoclar Vivadent, Incorporated, stating that the device is substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information regarding acceptance criteria, device performance testing, or study details such as sample size, data provenance, expert consensus, adjudication methods, or comparative effectiveness studies.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. This type of information is typically found in the 510(k) submission itself or in a summary of safety and effectiveness, neither of which is present in the provided FDA letter.

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