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Abutment Design is intended as an aid to the restoration in partially or fully edentulous mandibles and maxillae. Abutment Design is intended for use by a dental practitioner or dental laboratory staff for designing the patient specific component of a two-piece, or hybrid dental implant abutment. The resulting abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

The Abutment Design software receives scan data containing topographical characteristics of real teeth, dental impressions, or stone models. The software provides the user with the ability to create matching endosseous dental implant abutments using computer aided design. The Abutment Design is restricted to be used with 510(k) cleared abutment systems, and the design output from Abutment Design (the patient specific part of the abutment) must be manufactured according to the instruction of the selected abutment system. The Abutment Design software includes design parameters from the 510(k) cleared abutment systems such as implant type, maximum and minimum dimensions (e.g., abutment post height, gingival height, angulation, gingival margin diameter, etc.). The design parameters, provided by abutment system manufacturers, for an abutment system are available via a 3Shape server when documentation of the 510(k) clearance of said implant system is presented to 3Shape. Abutment Design has no patient contact being a software only device.

3Shape Splint Design for splints and mouthguards is intended for use as a medical front-end device providing tools for systematic inspection, detailed analysis, treatment simulation and virtual appliance design based of 3D models of the patient's dentition before the start of an orthodontic treatment. The use of Splint Design software requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

The Splint design software for splints and mouthquards/nightquards is a software system used for the virtual planning of orthodontic treatments by simulating jaw movements, and design of orthodontic appliances based on 3D scanned orthodontic models. The realization of the above-mentioned orthodontic appliances is done using splint workflow which supports - Direct production using 3D printer or milling machines with FDA cleared or . listed materials included in the splint workflow. The actual production of appliances is done by the user and it is under their control and responsibility. 3Shape Splint Design has no patient contact being a software only device.

Ortho System™ for dental retainers and dental cast for sequential aligners is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options based on 3D models of the patient's dentition before the start of an orthodontic treatment. The use of the Ortho System™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

3Shape's Ortho System™ for dental retainers and dental cast for sequential aligners is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analysing, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, and design of orthodontic appliances based on 3D scanned orthodontic models. The realization of the orthodontic appliances are done using appliance workflows templates which either supports - . (Retainers and dental casts for sequential aligners) Thermoforming FDA cleared or listed material on a dental cast. The cast is designed and produced by machines and materials included in the appliance workflow template - (Retainers) Direct production using 3D printer or milling machines with FDA . cleared or listed materials included in the appliance workflow template. The Ortho System™ appliance workflow templates with approved machines is available through a dedicated download centre by the software. The instruction for use contains instructions for configuration of additive printers. The actual production of appliances/casts and any thermoforming is done by the user and is under their control and responsibility – only materials specified in the manual must be used to produce the final appliance. The Ortho System™ has no patient contact being a software.

The 3Shape Ortho System™ is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual applians (Custom Metal Bands, Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of the Ortho System™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

3Shape's Ortho System™ is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analysing, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models, including transfer methods for indirect bonding of brackets. Output includes only Export Model (also called dental casts), Custom Metal Bands (also called metal bands), and Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). All devices are to be fabricated from FDA cleared materials by third party under the responsibility of the user. The device has no patient contact.

3Shape Ortho System™ for dental retainers is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design based on 3D models of the patient's dentition before the start of an orthodontic treatment. The use of the Ortho System™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

3Shape's Ortho System™ is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzinq, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models. Output includes Dental Retainers. All devices are to be fabricated from FDA cleared or listed materials currently available in the software. The device has no patient contact.

3Shape Ortho System™ is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design of Splints, Mouthguards / Nightguards based on 3D models of the patient's dentition before the start of an orthodontic treatment. The use of the Ortho System™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

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The 3Shape Abutment Designer Software is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. The 3Shape Abutment Designer is intended for use by a dental practitioner or dental laboratory staff for designing the patient specific component of a two-piece, or hybrid dental implant abutment. The single or multi-unit abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

The 3Shape Abutment Designer™ Software receives scan data containing topographical characteristics of real teeth, dental impressions, or stone models. The software provides the user with the ability to create matching endosseous dental implant abutments using computer aided design. The output of the device is a computer file containing the abutment(s) in digital form which can be used by manufacturers that hold an implant abutment 510(k) or are milling per the specific instructions provided by the holder of a 510(k) marketing clearance for a patient specific implant abutment. The 3Shape Abutment Designer Software output is restricted in the U.S. to be manufactured by a holder of an implant abutment 510(k) or milled per the specific instructions provided by the holder of a 510(k) marketing clearance for a patient specific implant abutment. The 3Shape Abutment Designer™ Software can be run on properly configured "off-the-shelf" PC hardware running Microsoft® Windows and using a standard keyboard and mouse. The 3Shape Abutment Designer™ Software requires the loading of implant libraries, which includes information such as implant type, maximum and minimum dimensional parameters for abutments, etc., created by separate abutment manufacturers and cleared by the FDA. In the US, the Implant Libraries are obtained via a 3Shape server after demonstration to 3Shape of the FDA clearance of the Implant Library.

3Shape Ortho System™ is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Custom metal bands, Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodonic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned the amment objectives. The use of the Ortho System™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

3Shape's Ortho System™ is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzinq, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models, including transfer methods for indirect bonding of brackets. Output includes only Export Model (also called dental casts), Custom Metal Bands (also called metal bands), and Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). All devices are to be fabricated from FDA cleared materials. The device has no patient contact.