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510(k) Data Aggregation

    K Number
    K190112
    Device Name
    Non-Sterile Zirconia Block
    Manufacturer
    Fine Advanced Compound Co., Ltd
    Date Cleared
    2019-12-20

    (331 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K180252
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fine Advanced Compound Co., Ltd

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

    Non-Sterile Zirconia Block (Model: Finebase, Montblanc, Trione C, Trione HT+) are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

    Device Description

    Non-Sterile Zirconia Block (Model name: Finebase, Montblanc, Trione HT, Trione C, Trione HT+) is a manufacture unit that is cut, processed and sintered by CAD/CAM system of the computers designed for production of dental restoration.

    AI/ML Overview

    The provided text is a 510(k) Summary for a dental device (Non-Sterile Zirconia Block) and does not describe the acceptance criteria or a study that proves a device (likely an AI/ML-enabled medical device) meets acceptance criteria. The document explicitly states:

    "No clinical study is included in this submission." (page 4)

    Therefore, I cannot extract the requested information regarding acceptance criteria, performance studies, sample sizes, expert involvement, or adjudication methods from this specific document.

    The document focuses on non-clinical tests (material properties and biocompatibility) to demonstrate substantial equivalence to a predicate device, rather than clinical performance (e.g., accuracy of a diagnostic AI).

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