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510(k) Data Aggregation

    K Number
    K113431
    Device Name
    CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA
    Manufacturer
    BETTINI S.P.A.
    Date Cleared
    2012-03-30

    (130 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

    Bettini BZD Zirconia Blocks are indicated for use in preparation of crowns, facings, inlays, and onlays to produce a hard prosthesis with a porcelain-like finish. The blocks are frequently used with porcelain overlay for translucence and related effects, and they are utilized to fabricate copings and frameworks for inlays, onlays, veneers, crowns, and anterior and posterior bridge restorations.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a dental device, "Bettini BZD Zirconia Blocks." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    This type of document primarily confirms that the FDA has reviewed the device and determined it is "substantially equivalent" to legally marketed predicate devices. This determination is based on the information provided by the manufacturer in their 510(k) submission, which would typically include technical specifications, comparisons to predicate devices, and sometimes performance data, but that detailed study information is not present in this letter.

    Therefore, I cannot provide the requested information based on the input document.

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