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510(k) Data Aggregation

    K Number
    K161652
    Device Name
    DIAZIR
    Manufacturer
    ZXTGY (BEIJING) TECHNOLOGY CO., LTD
    Date Cleared
    2017-11-28

    (531 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

    DIAZIR Zirconia Dental Ceramics are indicated for the use of artificial teeth production for either fixed or removable dentures, or for jacket crowns, facings, veneers as well as bridge up to three units.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided document is a letter from the FDA regarding a 510(k) premarket notification for "DIAZIR Zirconia Dental Ceramics." It focuses on regulatory approval and general information rather than detailing specific acceptance criteria for performance, a study proving those criteria were met, or any of the technical specifics of a study about device performance.

    Therefore, I cannot extract any of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies from this document.

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