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Thommen VARIOeco dental implant 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.

VARIOeco abutments are titanium dental implant abutments for use with Thommen System dental implants for fabrication of porcelain-fused-to-metal (PFM) restorations. VARIOeco includes two abutment designs, one for single tooth (crown) and one for multi-tooth (bridge) restorations. A laboratory burn-out cap and abutment screw are provided together with the abutment in the VARIOeco set. Both VARIOeco abutment designs are provided in five platform diameters (3.5, 4.0, 4.5, 5.0 and 6.0 mm) corresponding to Thommen System dental implants (ELEMENT, CONTACT and ONETIME).

Thommen SPI® VARIO Angled Abutments are intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for crowns or bridges.

SPI® VARIO Angled Abutments are titanium dental implant abutments for use with the SP1® Dental Implant system. They connect with the internal hex feature of the implant, have a precision fit interface with the prosthetic attachment, and are intended for screw retained restorations in single unit and small multi-unit solutions. SPI VARIO Angled Abutments are designed for correction of implant divergence and can be used in combination restorations with SPI VARIO abutments.

Thommen Titanium Base for CAD/CAM abutments are intended to be used in conjunction with Thommen implants and the 3M ESPE Lava™ System in the maxillary and/or mandibular arch to provide support for crowns and bridges.

Titanium Base for CAD/CAM provides a foundation for a customized CAD/CAM abutments and restorations. It is suitable for precision fit custom abutments or crown and bridge restorations fabricated with CAD/CAM technology provided separately by 3M ESPE as the Lava System. The Titanium Base for CAD/CAM in conjunction with the 3M ESPE Lava System is not intended to be used to fabricate angled abutments. Titanium Base for CAD/CAM is made from commercially pure titanium, grade 4 conforming to ASTM F67, and the corresponding abutment screw (cleared under K031747) is made of titanium alloy, Ti-6Al-7Nb conforming to ASTM F1295.

Thommen SPI® VARIOmulti Angled Abutments are intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for splinted crowns, bridges or overdentures.

SPI® VARIOmulti Angled Abutments are dental implant abutments for use with the SPI® Dental Implant System. They have an internal connection to the implant and are used for multi-unit, screw-retained, prefabricated restorations. VARIOmulti Angled Abutments are made of titanium and are available in diameters from 3.5 to 4.5 mm with an angle of 30° to the implant. The system includes dedicated prosthetic components including protective and temporary caps. SPI® VARIOmulti Angled Abutments are compatible with the Nobel Biocare Multi-unit Abutment System.

SPI® Dental Implant, ELEMENT is for one-stage or two-stage surgical procedures. SPI Dental Implant, ELEMENT is intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases. Contraindications for the use of SPI ELEMENT implant Ø 3.5 mm: These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements. - Restoration of posterior teeth in the upper and lower jaw . - Single-tooth restoration of canines and central incisors in the upper jaw . - Any application involving retentive anchors .

The design of the Thommen Medical AG SPI® Dental Implant System implants has been modified to include new sizes and corresponding abutments that will be marketed as the SPI® Dental Implant, ELEMENT. All features other than these implant sizes remain the same as the currently marketed SP1® ELEMENT implants. Other components of the SP10 Dental Implant System have not been modified, are suitable for use with the modified implants, and will be sold under the SPI Dental Implant System name.

The SPI® Customizable Gingiva Former is intended to be used in conjunction with SPI® System dental implants to provide temporary support for crowns or bridges in the maxillary and/or mandibular arch.

The Thommen SPI® Customizable Gingiva Former is a temporary endosseous dental implant component made from an acrylic-based polymer with a titanium base at the implant/abutment interface for a stable, precise connection. The SPT® Customizable Gingiva Former is used for maintaining gingival contour and as a base for fabrication of a temporary restoration.

SPI® Dental Implant, INICELL® is for one-stage or two-stage surgical procedures. SPI Dental Implant, INICELL is intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases. Contraindications for the use of SPI ELEMENT INICELL implant Ø 3.5 mm and SPI CONTACT INICELL implant Ø 3.5 mm: These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements. - Restoration of posterior teeth in the upper and lower jaw - Single-tooth restoration of canines and central incisors in the upper jaw - Any application involving retentive anchors

The design of the Thommen Medical AG endosseous dental implants has been modified to include a new surface treatment that will be marketed as the SP1® Dental Implant, INICELL® All features other than this surface treatment of the implants remain the same as the TST Surface implants. Other components of the SP1® Dental Implant System have not been modified, are suitable for use with the modified implants, and will be sold under the SPI Dental Implant System name.

Thommen SPI® VARIOmulti Angled Abutments are intended to be used in conjunction with SP1® System dental implants in the maxillary and/or mandibular arch to provide support for splinted crowns, bridges or overdentures.

SPI® VARIOmulti Angled Abutments are dental implant abutments for use with the SP10 Dental Implant System. They have an internal connection to the implant and an external hex prosthetic attachment, and are used for multi-unit, screw-retained, prefabricated restorations. The system includes dedicated prosthetic components.

Thommen SPI® VARIOmulti Abutments are intended to be used in conjunction with SPT® System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures.

SPI® VARIOmulti Abutments are dental implant abutments for use with the SP1® Dental Implant System. They have an internal connection to the implant and an external hex prosthetic attachment, and are used for multi-unit screw-retained, prefabricated restorations. The system includes dedicated prosthetic components. VARIOmulti Abutments are appropriate for supporting laboratory cast frameworks as well as machined titanium frameworks using the Nobel Biocare Procera® Implant Bridge Titanium.

SPI® System Dental Implants are for one-stage or two-stage surgical procedures. SPI System Dental Implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases. Contraindications for the use of SP1® ELEMENT implant Ø 3.5 mm and SP1® CONTACT implant Ø 3.5 mm: These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements. - Restoration of posterior teeth in the upper and lower jaw - - Single-tooth restoration of canines and central incisors in the upper jaw - - Any application involving retentive anchors -

Thommen SPI Dental Implants are self tapping, root form, endosseous dental implants made of commercially pure grade titanium. The intended use of the subject endosseous dental implants includes a six week healing period when conventional loading protocols are used, rather than the currently recommended twelve-week minimum healing period, as well as to permit immediate functional loading of single-tooth or multiple unit restorations when good primary stability is achieved.