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510(k) Data Aggregation

    K Number
    K020253
    Device Name
    4 ALL (DW286A)
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2002-04-17

    (83 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

    4 ALL (DW286 A) 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

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental alloy, "4 ALL (DW286 A)". This document does not contain any information about acceptance criteria or a study that proves a device meets those criteria.

    The letter primarily:

    • Confirms that the device is substantially equivalent to legally marketed predicate devices.
    • Outlines general regulatory requirements for marketing the device.
    • States the intended indications for use of the device.

    Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, training set details) because it is not present in the provided text.

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