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The Straumann CARES Visual/Nova Implant-borne CAD software are indicated for the design of two-piece or one-piece abutment components for single or multiple-unit implant-borne prosthetics for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners and CAD software. The system is used to design two-piece abutment CAD/CAM milled copings, crown and bridge restorations to be cemented onto Ti-bases, customized one-piece abutments and bridges/bars to be affixed to the endosseous dental implants using a basal screw. The use of the software requires the user to have the necessary training and domain knowledge in the practice of prosthetic design, as well as training in the use of the software.

Straumann CARES Visual/Nova is a dental CAD software to create implant-borne restorations. The software employs optical impression files that represent the topographical characteristics of the patient's intraoral situation. The Straumann CARES Visual/Nova software then allows the desired restorations. All implant-borne restorations available in Straumann CARES Visual/Nova software require FDA review and 510(k) clearance. Design specifications ("design envelope"), selectable materials, mouth positions need to be described in these 510(k) submissions. Each restorative solution is defined in a secured design library that provides the CAD software with the design specifications and restrictions for instance, minimum wall thickness, maximum angulation, cementable abutment post height etc. Standard connecting geometries e.g., abutment to implant interface are also defined in the library which cannot be edited by a user. Any dental implantborne restoration can only be created within the 510(k)-cleared design envelope. The output of the CAD software is a three-dimensional geometry file which is linked to meta data like material and patient identifier. All designed implant-borne restorations are intended to be: - sent to Straumann for manufacturing by a validated milling center, or . - milled on a validated Straumann C series or M series milling machine (only . with the CARES Visual software, K171649 and K203456) - 3D printed as a temporary crown, or temporary bridge (up to 180 days) using P pro . Crown & Bridge material on a validated Straumann P series printer (only with the CARES Visual software, K203750) Straumann CARES Visual/Nova has no patient contact since it is software.

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

CloudPoint FastDesign Chairside (also known as FastDesign), is a software suite intended to be used by trained dental practitioners or dental laboratory staff to design the patient-matched component of a two-piece hybrid dental implant abutment. A titanium base-type abutment and hybrid abutment-crown component are combined to make the two-piece hybrid dental implant abutment. The software allows a dental practitioner or dental laboratory staff to design the matching dental abutment based on imported scan data containing topographical characteristics of the patient's dentition. The resulting abutment design will be exported to a remote milling machine to make the final device. CloudPoint FastDesign Chairside, is restricted to be used with 510(k) cleared abutment systems. The software includes design parameters from the 510(k) cleared abutment systems such as maximum and minimum dimensions (e.g., abutment post height, gingival height, angulation, gingival margin diameter, etc.). CloudPoint FastDesign Chairside designs the endosseous dental implant abutment under the directions of a clinical professional and maintaining accordance to the requirements of the compatible 510(k) cleared abutment systems with cleared design parameter size ranges.

TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxillae. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxilla. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device. TRUST is restricted to be used with 510(k) cleared abutment systems, and the design output from TRUST (the patient specific part of the abutment) must be manufactured according to the instruction of the selected Implant system. TRUST includes design parameters from the 510(k) cleared abutment systems such as implant type, maximum and minimum dimensions (e.g., abutment post height, angulation, gingival marqin diameter, wall thickness). The design parameters, provided by abutment system manufacturers(Truabutment), for an abutment system are available via a Trust server when documentation of the 510(k) clearance of said implant system is confirmed by Rgorithm. TRUST has no patient contact being a software only device. (stand-alone software)

The AbutmentCAD module is intended as an aid to the restoration in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

AbutmentCAD is a software application for the purpose of designing patient-specific implant-based dental restorations, such as one-piece abutments, two-piece/hybrid abutments and single or multi-unit screw retained restorations. The AbutmentCAD software can be used with basic dental CAD systems such as exocad's ChairsideCAD. AbutmentCAD is used solely for the patient-specific components of abutments and screw retained crowns and bridges. The software application runs on "off-the-shelf" PC hardware with current Microsoft Windows operating system and standard peripheral components.

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.

The Sirona Dental CAD/CAM System with InLab Software is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the BH 3.0 S, SSO 3.5 L and SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. The system consists of three major parts: TiBase, inCoris mesostructure, and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructures may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.xxxx) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems: (list of compatible implant systems and sizes follows).

The Sirona Dental CAD/CAM System with InLab Software is a modification to the Sirona Dental CAD/CAM System as previously cleared under K111421. The modifications represented in the subject device consist of the implementation of functionality for the control of critical CAD/CAM abutment dimensions. The subject Sirona Dental CAD/CAM System with InLab Software consists of: InLab SW version 18.5, "labside" CAD/CAM software, InEos X5 3D digital desktop scanner, InEos Blue 3D digital desktop scanner, InLab MC X5 milling unit, InLab MCXL milling unit, Sirona TiBase titanium base components, inCoris ZI zirconium mesostructure blocks. The system is utilized to digitally acquire and/or record the topographical characteristics of teeth, dental impressions, or physical stone models in order to facilitate the computer aided design (CAD) and computer aided manufacturing (CAM) of two-piece "CAD/CAM" abutments. The patient-specific two-piece abutments consist of pre-fabricated "TiBase" components and the zirconium ceramic mesostructure component which is designed using the InLab software and milled using the InLab milling equipment. The completed mesostructure is cemented to the TiBase component using PANAVIA F 2.0 dental cement.

DTX Studio design software is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. DTX Studio design software is intended to be used by dental laboratory staff or a dental practitioner for designing patient specific component of a two-piece, one-piece or hybrid dental implant abutment. The single or multiple patient specific abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

DTX Studio design is a stand-alone software platform that integrates CAD software to render a design of a dental abutment. The software receives surface scan data containing topographical characteristics of real teeth, position and orientation of implants and uses also an integrated third-party software to perform the CAD design of the dental abutment. Additional functions include creating and tracking cases. The output of the device is a computer file containing the dental abutment in a digital form.

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.