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510(k) Data Aggregation

    K Number
    K990817
    Device Name
    IPS D.SIGN PORCELAIN
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    1999-04-06

    (26 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended Use: d.Sign Porcelain is intended to be used for inlays, onlays, veneers, and anterior/posterior crowns.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a dental device called "IPS D.Sign Porcelain". This document primarily focuses on the regulatory approval of the device and does not contain information about acceptance criteria, clinical studies, or performance metrics in the way you've described.

    Therefore, I cannot extract the requested information regarding:

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

    This document confirms substantial equivalence to a predicate device and allows the manufacturer to market the product. It doesn't detail the specific testing and studies that would normally be associated with proving these performance criteria.

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