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Implant-One™ System Abutments are intended for use as an aid in prosthetic rehabilitation in the mandible or maxilla for support of single-unit or multi-unit restorations. The Implant-One Ti-Base Abutment consists of the titanium base and a mesostructure component, making up a two-piece abutment, and will be attached to the implant using an abutment screw. The mesostructure for use with the Implant-One Ti-Base is intended only to be designed and manufactured according to digital dentistry workflow that integrates scan files from lab scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

The subject devices comprise abutments designed for the 300, 400, and 500 Series of the Implant-One" system. All subject device abutments incorporate a Morse taper at the implant/abutment interface, have a hexagonal male end for alignment purposes and are screw retained. The series is grouped according to the implant/abutment interface size and each series is color coded for ease of identification. The subject devices are Titanium Base Abutments. The Implant-One™ Titanium Base Abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. The Implant-One" Titanium Base Abutments consist of two major components. Specifically, the titanium base and the mesostructured component make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling. The standard Ti Base Abutments are offered in cuff heights of 0.5mm, 1.5mm and have a Ø4.0mm profile for the 300 series and a Ø4.5mm profile for the 400 & 500 series. The following components are intended to be used for scanning, designing and manufacturing of ceramic mesostructures for the Implant-One™ Titanium Base Abutment: - Lab scanner: Medit/Identica T500 3D Scanner (Medit Corp) ● - CAD software (PNP): 3Shape Abutment Designer & Abutment Design (3Shape A/S -● K151455 & K200100) and exocad AbutmentCAD (exocad GmbH - K193352) - Ceramic material: Katana™ Zirconia (Kuraray Noritake Dental, Inc. K143439) ● - . Milling machine: Ceramill Motion 2 (Amann-Girrbach AG) - Milling software: Ceramill Match 2 CAM Software (Amann Girrbach AG) - Cement: RelyX™ Luting Plus Automix Cement (3M ESPE Dental Products K11185) ●

The Implant-One™ Multi-Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for prosthetic rehabilitation of the mandible or maxilla with a multi-unit restoration.

The subject devices comprise abutments designed for the 300, 400, and 500 Series of the Implant-One™ system. All subject device abutments incorporate a Morse taper at the implant/abutment interface, have a hexagonal male end for alignment purposes and are screw retained. The series is grouped according to the implant/abutment interface size and each series is color coded for ease of identification. The subject devices are Angled Multi-Unit Abutments. The Implant-One Multi-Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. The Implant-One Multi-Use Abutments are indicated for multiple-tooth restorations. Angled Multi-Unit Abutments are available for the 300, 400, and 500 series and used for multiple implant restorations such as screw retained dentures. These abutments are offered in cuff heights of 2.5 mm and 3.5 mm for all series.

The Implant-One™ System is indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The Implant-One™ system is indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.

Endosseous implants are self-tapping and threaded, and offered having root-form or wide thread forms. Root-form implant diameters range from 3.25mm to 5.5mm having lengths from 8mm to 14mm. Wide thread implant diameters are available in 4.1 and 4.5mm (8mm to 14mm lengths), 5.5mm (8mm to 12mm lengths) and 6.5mm (8mm to 10mm lengths). Cover screws and healing caps provide protection to the threads of the abutment connection during endosseous and gingival healing. Cover screws are pre- packaged with each implant. Healing caps are provided as an alternative to the cover screw and are packaged separately. The Implant-One™ dental implants and cover screws are provided sterile. Not all abutments can be used for single-unit restorations. The conical, angled conical, ball, locator and glueless abutments are intended only for multi-unit loaded restorations. The ball, locator and glueless abutments are to be used in fully removable dentures. The conical and angled conical abutments are to be used in screw retained dentures and with the titanium sleeve for screw retention. The final design parameters for the custom blank abutment are as follows: maximum total height, 12.5mm; minimum/maximum gingival height, 0.5mm/6mm; minimum post height, 4mm; maximum angulation, 30°; minimum wall thickness, 0.78 (at 1.5mm above the proximal end); minimum diameter, 3.75 mm for the 300 Series, 4.25 mm for the 300 Series and 4.75 mm for the 500 Series.