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510(k) Data Aggregation

    K Number
    K173643
    Device Name
    Trilor Disks, Blocks and Arches
    Manufacturer
    Bioloren S.R.L.
    Date Cleared
    2018-02-24

    (89 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bioloren S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Trilor Fiber Disks, Blocks and Arches are milling blanks composed of a multi-directional interlacing of fiberglass and resin in several layers. They are intended to be used 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
    Trilor Fiber Disks, Blocks and Arches are milling blanks composed of a multi-directional interlacing of fiberglass and resin in several layers.
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