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    K Number
    K121359
    Device Name
    IPS 99 ONE AND IPS 99 CERAM
    Manufacturer
    IVOCLAR VIVADENT AG
    Date Cleared
    2012-07-27

    (81 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IPS 99 ONE AND IPS 99 CERAM

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

    IPS 99 One is a one-layer veneering ceramic for the fabrication of metal-ceramic restorations using the most popular dental alloys in the CTE range of 13.8-15.0 x 10ªK (26.50°C)

    IPS 99 Ceram is a conventional multi-layer veneering ceramic for the fabrication of metalceramic restorations using the most popular dental alloys in the CTE range of 13.8-15.0 x 10ª/K (25-600°C).

    IPS 99 is intended to be used for inlays, onlays, veneers, and anterior/posterior PFM crowns.

    Device Description

    Not Found

    AI/ML Overview

    This looks like a 510(k) clearance letter for a dental ceramic product, not a study report for a medical device with performance metrics. Therefore, the requested information about acceptance criteria, study data, ground truth establishment, and expert involvement cannot be extracted from this document.

    The document states that the "IPS 99 One and IPS 99 Ceram" are "Porcelain Powder for Clinical Use" and are "intended to be used for inlays, onlays, veneers, and anterior/posterior PFM crowns." The letter confirms substantial equivalence to predicate devices, meaning it meets the regulatory requirements for marketing, but it does not include performance data or studies against specific acceptance criteria in the way a diagnostic or AI-powered device submission would.

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