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Implantswiss Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implantswiss Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implants. Implantswiss Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa and Multi-Unit Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture. All digitally designed Premill abutments for use with the Implantswiss Dental Abutment System are intended to be sent to a Novodent validated milling center for manufacture.

The Implantswiss Dental Implantswiss Dental Abutment Systems are compatible titanium/titanium alloy dental implants and abutments. This submission provides additional models to the existing family of implants and abutments. The Implantswiss Dental Implants are provided as bone level type implants and their surface is modified by a Sandblasted Rough Acid-etched (SRA) process. The additional devices added in this submission are all bone level implants, manufactured of pure titanium. The subject implant bodies have the same surface modification as the existing/cleared devices. The Implantswiss Bone Level Implants have diameters of 3.3 mm, 4.3 mm 4.8 mm, and 5.5mm with lengths of 8 mm. 10 mm. 12 mm. Additional implant models are 3.3 mm diameter implants with straight design and 3.7 mm diameter implants with hybrid design (tapered apex). The Implantswiss Dental Abutment System is used in combination with Implantswiss dental implants to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. The Implantswiss Dental Abutment System consists of provisional (temporary) and final type abutments, abutment screws, and the Healing Cap, a protective cover. The dental abutment provides the link between the dental implant and the prosthetic restoration that restores the chewing function. The Implantswiss Dental Abutment System consists of Healing, Solid, Couple, Angled, Multi, O-ring, Multi-Unit. Premill, and Locator abutments with diameters 0 5.5 mm. 0 6.5 mm. 0 6.5 mm have lengths of 8.9 mm, 9.9 mm, 11.9 mm, 12.9 mm and 10.4 mm, 11.4 mm, 12.4 mm, 13.4 mm, 14.4 mm. Non-hex Couple abutments with diameters Ø 5.5 mm, Ø 6.5 mm have lengths of 8.7 mm, 9.7 mm, 10.7 mm, 11.7 mm and 12.7 mm. Bone Level Angled Abutments with 15° angles have diameters Ø 5.5 mm with lengths varying from 10.57 mm to 12.57 mm. Bone Level Angled Abutments with 25° angles have diameters Ø 5.5 mm, Ø 6.5 mm with lengths varying from 11.06 mm to 13.13 mm. Non-hex Bone Level Angled Abutments with 15° angles have diameters Ø 5.5 mm, Ø 6.5 mm with lengths varying from 10.37 mm to 12.38 mm. Nonhex Bone Level Angled Abutments with 25° angles have diameters Ø 5.5 mm, Ø 6.5 mm with lengths varying from 10.86 mm to 12.93 mm. Tissue Level Angled Abutments have 15° angles with diameter Ø 3.5 mm with length 9.8 mm. Bone Level Solid Abutments have diameters of Ø 5.5 mm and Ø 6.5 mm with lengths between 12.4 mm to 16.4 mm. Bone Level O-ring Abutments have diameters of Ø 3.42 mm and Ø 3.7 mm with lengths between 10.1 mm to 13.1 mm. Tissue Level O-ring Abutments have a diameter of 3.5 mm with lengths 9.1 mm, 11.1mm and 13.1 mm. Bone Level Multi Abutments have diameter of Ø 5.5 mm with length 15.63 mm. Non-Hex Bone Level Multi Abutments have a diameter of Ø 5.5 mm with length 15.63 mm. Bone Level Healing Abutments have diameters of Ø 5.5 mm with lengths 9.5 to 13.5 mm. Tissue Level Healing Abutments have diameter of Ø 6.4 mm with lengths 7.4 mm, 8.4 mm and 9.9 mm. Bone Level Locator Abutments have diameter of Ø3.86 mm with length 13.95 mm. Bone Level Multi-Unit Abutments have a diameter Ø 4.8 mm with lengths 8.45 mm and 12.65 mm. Bone Level Multi-Unit Abutments with 17° angle have a diameter Ø 4.8 mm with length 7.2 mm. Bone Level Multi-Unit Abutments with 25° angle have a diameter Ø 4.8 mm with lengths 7.5 mm, 8.5 mm and 9.5 mm. Bone Level Premill Abutments have pre-mill diameters of Ø 10 mm, Ø 14 mm and Ø 16 mm with length 33.75 mm. Tissue Level Premill Abutments have pre-mill diameters of Ø 10 mm, Ø 14 mm and Ø 16 mm with length 30.08 mm. The finished premill custom abutment diameter is Ø 4.0 mm.

Implantswiss Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implantswiss Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implantswiss Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa and Multi-Unit Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture.

The Implantswiss Dental Implant and Implantswiss Dental Abutment Systems are compatible titanium/titanium alloy dental implants and abutments. The Implantswiss Dental Implants are provided as bone level or tissue level type implants and their surface is modified by a Sandblasted Rough Acid-etched (SRA) process. The Implantswiss Bone Level Implants have diameters of 3.3mm, 3.7mm, 4.3mm and 4.8mm with lengths of 8mm, 12mm and 14mm; and diameter of 5.5mm with lengths of 8mm, 10mm and 12mm. The 3.3mm and 3.7mm diameter Bone Level Implants are composed of Titanium Ti6Al4V ELI – ASTM F136-13. The 4.3mm, 4.8mm and 5.5mm diameter Bone Level Implants are composed of Titanium Grade 4 – ASTM F67-13. The Implantswiss Tissue Level Implants have diameters of 3.7mm, 4.3mm and 4.8mm with lengths of 8mm, 10mm, 12mm and 14mm; and diameter of 5.5mm with lengths of 8mm, 10mm and 12mm. The Tissue Level Implants are composed of Titanium Grade 4 – ASTM F67-13. The Implantswiss Dental Abutment System consists of Couple, Angled, Solid, O-ring, Multi, Octa, Synocta, Healing, Locator and Multi-Unit Abutments.