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510(k) Data Aggregation

    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bicon, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
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    K Number
    K133608
    Device Name
    TRINIA
    Manufacturer
    BICON, LLC
    Date Cleared
    2014-03-14

    (109 days)

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

    BICON, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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, removable dentures, 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
    TRINIA is a fiber machining disk block. It is made of layers of glass fibers kept together by epoxy resin. TRINIA products are designed for the manufacturing of non-metallic dental appliances. The dental appliance is machined either by a CAD/CAM machine or by using the copying technique. TRINIA already possesses the mechanical characteristics needed for producing these dental appliances; no curing is necessary at the dental lab to make the product function properly.
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    K Number
    K101849
    Device Name
    BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT
    Manufacturer
    BICON, LLC
    Date Cleared
    2010-10-01

    (92 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    BICON, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3.0 mm Bicon implants are designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework, support of the res, or as a single tooth replacement. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage implantationoroach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. The 3.0 Bicon implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors.
    Device Description
    Not Found
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    K Number
    K092035
    Device Name
    BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION
    Manufacturer
    BICON, LLC
    Date Cleared
    2009-10-15

    (101 days)

    Product Code
    DZE, NHA
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    BICON, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bicon implant is designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a final or intermediate abutment for fixed bridgework or for partial dentures, or as a single tooth replacement.
    Device Description
    Not Found
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    K Number
    K073368
    Device Name
    5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT
    Manufacturer
    BICON, LLC
    Date Cleared
    2008-10-10

    (315 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    BICON, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 5.0 x 5.0mm and the 6.0 x 5.0mm implants are designed as a one stage or two stage surgical procedure implant for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework, partial dentures, or a single tooth replacement
    Device Description
    Not Found
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