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510(k) Data Aggregation

    K Number
    K013809
    Device Name
    D.SIGN 59
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2002-02-07

    (84 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 59

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

    d.SIGN 59 alloy intended to be used for onlay, ¾ crows, telescope crowns, conus crowns, posts, short and long span bridges, PFM crowns.

    Device Description

    d.SIGN 59 alloy

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a dental alloy named "d.Sign 59," confirming its substantial equivalence to a legally marketed predicate device.

    Therefore, I cannot provide the requested information, including:

    1. A table of acceptance criteria and reported device performance
    2. Sample size and data provenance for a test set
    3. Number and qualifications of experts for ground truth
    4. Adjudication method
    5. MRMC comparative effectiveness study details
    6. Standalone performance details
    7. Type of ground truth used
    8. Sample size for the training set
    9. How ground truth for the training set was established
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