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510(k) Data Aggregation

    K Number
    K171795
    Device Name
    Thommen Implant System
    Manufacturer
    Thommen Medical AG
    Date Cleared
    2017-09-29

    (105 days)

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

    Thommen Medical AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Implant: The ELEMENT PF 3.0 is suitable for use in one-stage or two-stage surgical techniques for restoring chewing function. The ELEMENT PF 3.0 is suitable for immediate implantation in case of replacement of several teeth; prerequisites are good primary stability and appropriate occlusal loading. The ELEMENT PF 3.0 must only be used for replacement of the lateral incisors of the upper jaw and lateral incisors of the lower jaw. VARIOunite PF 3.0: Thommen Medical VARIOunite abutments PF 3.0 are only used in conjunction with the ELEMENT PF 3.0 and are for fabrication of provisional and final crowns in the anterior maxilla and mandible (upper lateral incisors, lower anterior teeth). Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture. VARIOunite: Thommen Medical VARIOunite abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures. Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.
    Device Description
    ELEMENT Ø 3.0 is a self-tapping, root form, endosseous dental implant made of commercially pure titanium. It is provided in two surfaces (TST and INICELL) and five lengths (8.0, 9.5, 11.0, 12.5, and 14 mm). Subject device components available for the ELEMENT Ø 3.0 implant are the healing cap, gingiva former and VARIOunite abutments. VARIOunite abutments can be used for temporary restorations, permanent restorations, or CAD/CAM zirconia superstructures. The indications for previously cleared VARIQunite abutments have been expanded to include angulation of the CAD/CAM zirconia superstructures.
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    K Number
    K160244
    Device Name
    VARIOunite
    Manufacturer
    Thommen Medical AG
    Date Cleared
    2016-06-02

    (122 days)

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

    Thommen Medical AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VARIOflex Thommen Medical VARIOflex Abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures. VARIOtemp Thommen Medical VARIOtemp Abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.
    Device Description
    VARIOunite is a straight titanium dental implant abutment with retention groves that can be used for either permanent or temporary screw-retained or cement-retained restorations. Labeled as VARIOflex, it is provided with a burn-out sleeve for fabrication of a permanent restoration. Labeled as VARIOtemp, it is provided with a fabrication screw for fabrication of a temporary restoration. VARIOunite can be prepared to the appropriate occlusal height prior to fabrication of the restoration using the retention rings for guidance. VARIOunite is available with an indexed connection for crowns or a non-indexed connection for bridges. It is available in five platform diameters (3.5, 4.0, 4.5, 5.0 and 6.0 mm) corresponding to existing platform diameters of the Thommen System dental implants.
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    K Number
    K151984
    Device Name
    Thommen Milling Abutment for CAD/CAM
    Manufacturer
    THOMMEN MEDICAL AG
    Date Cleared
    2016-03-10

    (237 days)

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

    THOMMEN MEDICAL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Thommen Milling abutments for CAD/CAM are intended to be used in conjunction with Thommen System dental implants in the maxillary and /or mandibular arch to provide support for crowns, bridges and overdentures. All digitally designed abutments for use with Thommen Milling abutments for CAD/CAM are intended to be sent to a Thommen validated milling center for manufacture.
    Device Description
    The Milling Abutment for CAD/CAM is an abutment used by a dental laboratory equipped with the 3Shape CAD/CAM System to fabricate a customized abutment made of titanium. Each patient-specific abutment is individually prescribed by the clinician. Minimum wall thickness allowed for the final abutment is 0.4 mm, maximum angulation is 20°, maximum gingival height is 7.0 mm, and total height of the abutment is no greater than 15 mm and no shorter than 4.5 mm. All digitally designed abutments for use with Thommen Milling abutments for CAD/CAM are intended to be sent to a Thommen validated milling center for manufacture. Final abutments are to be sterilized prior to intraoral placement. Milling Abutment for CAD/CAM is available in five diameters (3,5 mm, 4,0 mm, 5,0 mm, 6,0 mm) and two heights (12 mm and 15 mm). The Ø3.5 mm abutment is provided in the 12 mm height. All other diameters are provided in the 15 mm height. Each abutment is supplied with a corresponding screw. Milling Abutment for CAD/CAM is compatible with the Thommen Implant System ELEMENT and CONTACT implants.
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