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510(k) Data Aggregation

    K Number
    K014042
    Device Name
    D.SIGN 84
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2002-02-22

    (77 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    D.SIGN 84

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    d-Sign 84 is intended to be used with conventional feldpathic porcelains. Also a-olgh 04 intended to be assa mas, conus crowns, conus crowns, posts, attachments, short and long span bridges, and PFM crowns.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for a dental alloy, D.SIGN 84. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device, a diagnostic device, or any device that would have measurable performance characteristics like sensitivity, specificity, or accuracy against ground truth.

    Therefore, I cannot extract the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, not on specific performance metrics or clinical study results as you would expect for the type of questions asked.

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