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510(k) Data Aggregation

    K Number
    K070935
    Device Name
    T.B.R. ZIRCONNECT
    Manufacturer
    Date Cleared
    2007-11-09

    (220 days)

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

    SUDIMPLANT SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The T.B.R.® Zirconnect endosseous dental implant is a device intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
    Device Description
    The T.B.R.® Zirconnect dental implant system consists of root form, screw-type implants (made from Ti-6Al-4V ) and restorative components with many options such as Ti-6Al-4V abutments, conical abutments. castable abutments and ball abutments. The system also includes surgical and laboratory accessories. Implants are double-packaged and provided sterile. Implants surface is roughened to promote osseointegration.
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    K Number
    K050956
    Device Name
    TBR IDEA CONIC/CONIC
    Manufacturer
    Date Cleared
    2006-02-16

    (307 days)

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

    SUDIMPLANT SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The T.B.R.® ide@ conic endosseous dental implant is a device intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
    Device Description
    Description of the donic/Conic dental implant system consists of selftapping threaded screw-type implants (made from Ti-6AI-4V ) and tapping througou overs with many options such as Ti-6Al-4V abutments, tapered abutments, castable abutments, ball abutments and ceramic/Titapered abutments. The system also include surgical and laboratory ord av abutiments. Implants are double-packaged and provided sterile. Implants surface is roughened to promote osseointegration.
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