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510(k) Data Aggregation

    K Number
    K090081
    Device Name
    TALLADIUM INTERNATIONAL IMPLANTOLOGY ABUTMENTS
    Date Cleared
    2010-06-22

    (526 days)

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

    TALLADIUM ESPANA S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Talladium abutments are used in connection with the prosthetic restoration of dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. The Talladium abutments fit implants with external hexagon, conical, conical, and other internal (e.g., multi-lobed) implants. A dynamic abutment is available to correct the angulation of an implants. . the the angulation of the dynamic abutments to 20° off of the long axis of the inplant). The Talladium abutments have been tested with the following implant systems: - Group 1, External Hexagon Abutments: 31 Implant Innovations, Biomet . - . Group 2, Conical Abutments: Nobel Biocare Multi-Unit - . Group 3, Internal Conical Abutments: Zimmer Screw-Vent SD - Group 4, Internal Abutments: Nobel Biocare Replace RP . Talladium abutments are compatible with the following implants: 3 i Implant Innovations Biomet, Innova, Life-Core, Nobel Biocare, Implamed, Zimmer, IMZ, Bti, Klockner external hexagon implants; Straumann and Nobel Biocare conical implants; Inc., Inc., Inc., Zimmer, BioHorizons and Blue Sky Bio internal hexagonal implants; and Nobel Biocare and Blue Sky Bio Trilobe platform internal connections.
    Device Description
    The Talladium abutments are an artificial tooth abutment designed to fit and function on root-form endosseous implants having various abutment interfaces: an external hexagon. conical, internal conical, and other internal connections such as multi-lobed. Talladium also has a dynamic abutment to correct the angulation of an implant if necessary. Talladium's abutments are intended for use in the treatment of partially edentulous patients in order to restore chewing function. The Talladium abutments are prosthetic abutments that fit a variety of endosseous implants listed below. Talladium's abutments are made from tilite, a biocompatible Base Metal Alloy material that is used in dental restorations.
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