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510(k) Data Aggregation

    K Number
    K111935
    Device Name
    TI-BASE ABUTMENT, 1 CONNECT ABUTMENT
    Manufacturer
    NT-TRADING GMBH AND CO KG
    Date Cleared
    2012-02-17

    (224 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    NT-TRADING GMBH AND CO KG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ti-Base for individual Zirconium Abutments: The devices covered by this submission are abultments which are placed into a dental implant to provide support for a prosthetic restoration. The Ti-Base for individual Zirconium Abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The Ti-Base abutments are indicated for use with the following implant systems: - Nobel Biocare® Replace Select® . - Nobel Biocare NobelActive TM . - Biomet 3i® Osseotite® . - Biomet 3i® Osseotite® Certain® . - Nobel Biocare Branemark® ● - Straumann® synOcta® . - Straumann® Bone Level® . - Zimmer® Tapered Screw-vent® . - Astra Tech OsseoSpeed® . - Dentsply-Friadent® Frialit® . 2-CONnect Abutment for Bridges and Bars: 2-CONnect for Bridges and Bars is indicated for use to provide support for prosthetic restorations such as bars and bridges. The 2-CONnect abutments can be used in multiple tooth restorations. The 2-CONnect abulment can be used together with cemented bridges and bar constructions for functional and aesthetical reconstruction. The 2-CONnect abutments are indicated for use with the following implant systems: - Nobel Biocare® Replace Select® . - Straumann® synOcta® . - Straumann® BoneLevel® .
    Device Description
    The Ti-Base Abutment is a premanufactured prosthetic component supplied in two parts, the abutment and screw, for fixation onto dedicated endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. The 2-CONnect Abutment consists of 1 Abutment with screw (for fixation of abutment to the implant) and 1 titanium cap with 1 tiny screw (fixed into the hollow Abutment screw). The cap on top fits exactly to the abutment-geometry and does not have a rotation fixation, so it is easier to work with (not indicated for single crowns but strictly for bridges). The 2-CONnect is intended for use as an aid in prosthetic rehabilitation. The NT-Trading Ti-Base and 2-CONnect is compatible, with commercially available dental CAD/CAM systems, such as 3Shape, Exocad, Dental Wings. Such systems must be validated by the user.
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