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510(k) Data Aggregation

    K Number
    K121735
    Device Name
    FIBER DISK AND BLOCK PERMANENT, TRINIA
    Manufacturer
    BIOLOREN SRL
    Date Cleared
    2013-02-21

    (253 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 DISK AND BLOCK PERMANENT, TRINIA

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

    Fiber Disks and Blocks 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 only copings, substructures or frameworks for permanent and transitional anterior or posterior crowns, bridgework and substructures that can be for either cemented or uncemented restorations e.g., telescopic restorations.

    Device Description

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

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Bioloren Srl for a dental product called "Fiber Disk And Block Permanent, Trinia." This document does not describe acceptance criteria, a study that proves the device meets acceptance criteria, or any details about a study's methodology or outcomes.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence to existing devices, not on specific performance data or study results.

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