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The NobelProcera® Zirconia Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

The NobelProcera Zirconia Implant Bridge (Dental Bridge) is a patient-specific, dental implant supported, screw-retained dental implant bridge which is connected to compatible Nobel Biocare root-form endosseous dental implants (Dental Implants) or Multi-unit Abutments and is intended to restore chewing function in partially and fully edentulous patients. The Dental Bridge is available as either a Framework requiring veneering in a dental lab or as a Full Contour design requiring minimum laboratory processing. The Dental Bridge is made from yttria-stabilized tetragonal zirconia. It is designed in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using dental CAD/CAM software and approved dental scanner. The finished design is sent to Nobel Biocare manufacturing facility for industrial production. After production, the Dental Bridge is sent to the laboratory for finishing. The Dental Bridge is available for use with Nobel Biocare's Dental Implants having Internal Conical Connection (CC), External Hex Connection, Internal Tri-Channel Connection and Nobel Biocare's Multi-unit Abutment connections. One Dental Bridge can feature connections to 2 up to 10 Dental Implants. All Dental Bridges are provided with the required Clinical and/or Prosthetic Screw: The Clinical Screw connects the Dental Bridge with the Dental Implant. The Prosthetic Screw connects the Dental Bridge with a Multi-unit Abutment. Dental Bridge connections on the Internal Conical Connection Dental Implant require use of Clinical Metal Adapters. Clinical Metal Adapters are provided with the Dental Bridge. No adapter is needed for the External Hex, Internal Tri-Channel, or Multi-unit Abutment connections. Clinical and Prosthetic Screws are placed from the occlusal side of the restoration. To facilitate access to the connection of the restoration to the implant/abutment a screw channel must be designed into the restoration. The Dental Bridge feature an Angulated Screw Channel (ASC) when connected to a Dental Implant with Internal Conical Connection and has an ASC feature to connect to Multi-unit Abutments. NobelProcera Zirconia Implant Bridges ASC's angulation can be defined by the customer in an angulation (to the implant's or Multi-unit Abutment's axis) between 0° and 25°. The ASC allows access through a screw channel which is not in line with the implant.

NobelProcera® Titanium ASC Abutments: NobelProcera® Abutment Titanium is a patient-matched CAD/CAM prosthetic component directly connected to endosseous dental implants and is indicated for use as an aid in prosthetic rehabilitation. Omnigrip Clinical Screw Titanium: Clinical and Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.

The Subject Device NobelProcera® Titanium ASC Abutment is composed of two device lines: NobelProcera® Titanium ASC Abutment and the Clinical Screw Omnigrip Titanium. NobelProcera® Titanium ASC Abutment is a patient matched CAD/CAM dental prosthesis which is connected to the Nobel Biocare implants featuring an internal conical and/or internal tri-channel connection, is available in the platform sizes NP, RP WP and 6.0 (for internal tri-channel connection only) and is intended for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance. NobelProcera® Titanium ASC Abutments undergo patient matched customization at a Nobel Biocare production facility for the final, finished abutment device manufacturing. NobelProcera® Titanium ASC Abutment is connected to the implant with a clinical screw and features an angulated screw channel which can be defined by the customer in an angulation (to the implant's axis) between 0° and 25°, in addition the abutment can be angulated to a maximum of 30°. The clinical screw features the Omnigrip Interface which allows tightening up to 25°. NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium are composed of titanium vanadium alloy Ti6Al4V ELI (ISO 5832-3, ASTM F136) and the surface of the abutments are provided with and without anodization and the Omnigrip Clinical Screw Titanium are provided with and without DLC coating. The finished NobelProcera® Titanium ASC Abutment supports the placement of a cement-retained dental prosthesis. Omnigrip Clinical Screw Titanium is available for the NP, RP, WP and 6.0 (for internal tri-channel connection only) platform, the devices connect the NobelProcera Titanium ASC Abutments to the dental implants. The devices feature an Omnigrip interface.

DTX Studio Clinic is a software program for the acquisition, management, transfer and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental restorative solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations. It can be used to support guided implant surgery whereby the results can be exported. DTX Studio Clinic is a computer assisted detection (CADe) device that analyses intraoral radiographs to identify and localize dental findings, which include caries, calculus, periapical radiolucency, root canal filling deficiency, discrepancy at the margin of an existing restoration and bone loss. The DTX Studio Clinic CADe functionality is indicated for use by dentists for the concurrent review of bitewing and periapical radiographs of permanent teeth in patients 15 years of age or older.

DTX Studio™ Clinic is a software interface for dental/medical practitioners used to analyze 2D and 3D imaging data, in a timely fashion, for the treatment of dental, craniomaxillofacial and related conditions. DTX Studio Clinic displays and processes imaging data from different devices (i.e. Intra/Extra Oral X-Rays, (CB)CT scanners, intraoral and extraoral cameras). DTX Studio Clinic features an Al-powered Focus Area Detection algorithm which analyzes 2D intraoral radiographs for potential dental findings or image artifacts. The detected focus areas can be converted afterwards to diagnostic findings after approval by the user. The following dental findings can be detected by the device: • Caries · Discrepancy at marqin of an existing restoration · Periapical radiolucency - Root canal filling deficiency • Bone loss · Calculus

Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured prosthetic component directly connected to an endosseous dental implant and is indicated for use as an aid in prosthetic rehabilitation for single units and multiple units of up to three units. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

The Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured titanium abutment which can be customized via a validated CAD/CAM workflow in the dental office or dental laboratory to meet patient-specific anatomical requirements. The customization of the subject device is designed using a dental laboratory software and milled in the dental laboratory, using a Computer Aided Design (CAD)/Computer Aided Manufacturing (CAM) machine. All digitally designed CAD/CAM customizations for the Titanium Abutment Blank Nobel Biocare N1™ TCC are only intended to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories. The subject device has a premanufactured connection for the Nobel Biocare N1 ™ TCC TiUltra implants on one end and a premanufactured connection for the milling blank holder on the other end. These connections are not patient-specific. The subject device is available for NP and RP implant platforms. The subject device is used by dental healthcare professionals in dental offices and dental laboratories. The subject device is composed of titanium vanadium alloy Ti6Al4V ELI (ISO 5832-3, ASTM F136) and features a surface with the same anodization already cleared in K211109. It is an implantable single use device. The device is provided non-sterile and intended to be sterilized by the user prior to placement in the patient. The Titanium Abutment Blank Nobel Biocare N1™ TCC is packaged with a Clinical Screw NB N1 TCC.

DTX Studio Clinic is a computer assisted detection (CADe) device that analyses intraoral radiographs to identify and localize dental findings, which include caries, calculus, periapical radiolucency, root canal filling deficiency, discrepancy at margin of an existing restoration and bone loss. The DTX Studio Clinic CADe functionality is indicated for the concurrent review of bitewing and periapical radiographs of permanent teeth in patients 15 years of age or older.

DTX Studio Clinic features an AI-powered Focus Area Detection algorithm which analyzes intraoral radiographs for potential dental findings or image artifacts. The detected focus areas can be converted afterwards to diagnostic findings after approval by the user. The following dental findings can be detected by the device: Caries, Discrepancy at margin of an existing restoration, Periapical radiolucency, Root canal filling deficiency, Bone loss, Calculus.

DTX Studio Clinic is a software program for the acquisition, management, transfer and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental restorative solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.

DTX Studio Clinic is a software interface for dental/medical practitioners used to analyze 2D and 3D imaging data, in a timely fashion, for the treatment of dental, cramomaxillofacial and related conditions. DTX Studio Clinic displays and processes imaging data from different devices (i.e. intraoral X-Rays, (CB)CT scanners, intraoral scanners, intraoral and extraoral cameras).

The NobelProcera® Zirconia Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

NobelProcera Zirconia Implant Bridges (Dental Bridges) are patient-specific, dental implant supported, screw-retained dental implant bridges which are connected to compatible Nobel Biocare root-form endosseous dental implants or Multi-unit abutments and are intended to restore chewing function in partially and fully edentulous patients. The Dental Bridge is available as either a Framework requiring veneering in a dental lab or as a Full Contour design requiring minimum laboratory processing. NobelProcera Zirconia Implant Bridges are made from 'Nacera Pean' (yttriastabilized tetragonal zirconia), Reference Device #1, K143071. The Dental Bridges are designed in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using dental CAD/CAM software and a Nobel Biocare/KaVo-approved dental scanner. The finished design is sent to Nobel Biocare manufacturing facility for industrial production. After production, the Dental Bridge is sent to the laboratory for finishing. NobelProcera Zirconia Implant Bridges are available for use with Nobel Biocare's root-form endosseous dental implants (Dental Implants) havinq Internal Conical Connection (CC), External Hex Connection, Internal Tri-Channel Connection and Nobel Biocare's Multi-unit Abutment Connections (for MUA and MUA Plus). One Dental Bridge can feature connections to 2 to 10 Dental Implants. All NobelProcera Zirconia Implant Bridges are provided with the required clinical and/or Prosthetic Screw: The clinical screw connects the Dental Bridge with the Dental Implant. The Prosthetic Screw connect the Dental Bridge with a Multi-unit Abutment. Dental Bridge connections on the Internal Conical Connection Dental Implant require use of Clinical Metal Adapters. Clinical Metal Adapters are provided with the Dental Bridge. No adapter is needed for the external hex, internal tri-channel, or Multi-unit abutment connections.

DTX Studio Clinic is a software program for the acquisition, management, transfer and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental restorative solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.

DTX Studio Clinic is a software interface for dental/medical practitioners used to analyze 2D and 3D imaging data, in a timely fashion, for the treatment of dental, craniomaxillofacial and related conditions. DTX Studio Clinic displays and processes imaging data from different devices (i.e. Intraoral and extraoral X-rays, (CB)CT scanners, intraoral scanners, intraoral and extraoral cameras).

NobelActive TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. Nobel Active Tilltra implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Nobel Active TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible. NobelActive TiUltra 3.0 implants are indicated for single-unit restorations only. NobelReplace CC TiUltra NobelReplace CC Tilltra implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations. The NobelReplace CC Tilltra implants can be used in splinted or non-splications. The NobelReplace CC TiUltra implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied. NobelParallel CC TiUltra NobelParallel CC TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function. NobelParallel CC TiUltra implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants with < 7 mm length are for delayed loading only when appropriate stability has been achieved. MUA Xeal The MUA Xeal is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. On1 Base Xeal The On1 Base Xeal device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. The On1 Universal Abutments consist of three major parts. Specifically, the On1 Base Xeal, the On1 Universal Abutment, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

The TiUltra implants and Xeal abutments are endosseous dental implants and abutments with an internal conical connection (CC) with hex interface. The TiUltra implants are comprised of three implant lines with various body shapes, range of diameters (3.0 - 5.5mm), and lengths (6.5 -18mm). The Xeal abutments are comprised of specific abutment types (i.e., straight, angled, and base). Both the TiUltra implants and Xeal abutments are made of titanium and feature a surface treatment that preserves the hydrophilicity of the device.

IPS CaseDesigner is indicated for use as a software and image segmentation system for the transfer of imaging information from a scanner such as a CT scanner. It is also indicated to support the diagnostic and treatment planning process of craniomaxillofacial procedures. IPS CaseDesigner facilitates the service offering of individualized surgical aids.

IPS CaseDesigner has specific functionalities to visualize the diagnostic information, e.g. from CT-imaging, to perform specific measurements in the image data and to plan surgical actions in order to support the diagnostic and treatment planning process. Based on the diagnostic and planning data, the IPS design service can offer individualized surgical aids.