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    K Number
    K143524
    Device Name
    Fiber Disks and Blocks (TRINIA)
    Manufacturer
    Bicon, LLC
    Date Cleared
    2015-06-02

    (172 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Fiber Disks and Blocks (TRINIA)

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

    Fiber Disks and Blocks (TRINIA) are milling blanks composed of a multi-directional interlacing of fiberglass and resin in several layers. They are intended to be used solely by dental technicians and dentists for making copings, substructures, or frameworks for permanent and transitional anterior or posterior crowns, and substructures that can be for either cemented or uncemented restorations (e.g. telescopic restorations).

    Device Description

    Fiber Disks and Blocks (TRINIA) are milling blanks composed of a multi-directional interlacing of fiberglass and resin in several layers.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental device (Fiber Disks and Blocks (TRINIA)), which primarily focuses on regulatory approval based on substantial equivalence to a predicate device. It does not include details about specific acceptance criteria for performance, a study to prove meeting those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

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