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TERA HARZ CLEAR is intended for the treatment of tooth malocclusions in patients with permanent dentition (i.e, all second molars). Utilizing a series of increments, it sequentially positions teeth by way of continuous gentle force. TERA HARZ CLEAR is intended exclusively for professional dental work. Fabrication of aligner with TERA HARZ CLEAR requires an additive manufacturing system (AMS) that includes compatible with the following : Design: Scanner 3Shape A/S TRIOS 3 Basic Design software 3Shape A/S 3Shape Ortho System™ Printing: 3D Printer UNIZ SLASH 2 UNIZ Nbee SprintRay Inc. SprintRay Pro 95 Post-Curing: Post-cure unit CureM U102H Tera Harz Cure THC

TERA HARZ CLEAR is a series of clear aligners that are used to replace traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. TERA HARZ CLEAR have 3 models : TC-85DAC, TR-07, TA-28. This series of aligner is intended for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars) by moves the teeth gently, and in small increments, from their original to their final treated position for improved dental alignment. This series of aligner is worn for approximately 1 week of 20 to 22 hours per day after (However, there are to be removed for eating and for cleaning) which it is replaced by the next stage aligners and are designed to be used in a sequence. This is repeated for duration as prescribed by the dental clinician. TERA HARZ CLEAR is a light-cured, methacrylate-based resin commonly can used in additive manufacturing for the production of dental structures such as sequential aligners. TERA HARZ CLEAR has stored in a black 1,000 g of HDPE bottle. It contains materials with colors of yellowish. This device is a liquid photo-curable material that is polymerized by UV laser at 405~412 nm. It can be used to make a tooth model with a photo-curable polymer that is cured by ultraviolet light. The liquid UV curing resin is cured at a specific wavelength (395~405 nm) by the photo-initiator contained in the resin. It is typically 100 um in thickness and is output at a resolution of 40 to 90 um on the x, y axis, and it is possible to produce threedimensional printed matter by curing lamination step by step a thickness of 100 um. However, scanner, design software, 3D printer and post-cure unit are not included with the device. These fabrications of TERA HARZ CLEAR are beginning with the dental clinician prescribing aligners to treat a patient's malocclusion, and decision to use methacrylate- based resins is made by the dental clinician. TERA HARZ CLEAR, an orthodontic appliance such as sequential aligner, is manufactured in a 3D printer that is compatible. The dental clinician can generate a digital file by scanning the patient's mouth directly using listed with Intraoral scanner under FDA Classification Product Code NOF, regulation872.3661. This digital file is a series of CAD files (.stl) for building models that can be used to fabricate aligners. Commonly used standard dental software is used by dental professionals to virtually design a sequential aligner and generate an industrystandard "STL" 3D dataset which reflects the intended shape and contour. The design software used is 3Shape Ortho System™ by 3Shape A/S (K180941). The specialized orthodontic treatment planning software has a 510k clearance for the intended use under FDA Classification Product Code PNN, regulation 872.5470. This software is used for management of 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, and design of sequential aligners based on 3D scanned orthodontic models. Once dental clinic manufacturing unit receive the data that *.stl CAD files of the treatment plan the 3D printer begins additive manufacturing. The dental clinician generates sequential 3D printed models replicating the approved treatment plan. The sequential aligner is 3D printed and cured in a post-cure unit. The fabricated aligners are cut to fit dentition, the cleaned and polished to remove rough edges by the dental clinician. The prescribing physician review and approves the sequential aligners areprovides them to the patient the confirming fit and design.

TERA HARZ II is intended as an indirect restorative for both anterior restorations, including occlusal surfaces. The TERA HARZ II material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit.

The TERA HARZ II is a light-cured, methacylate oligomer based polymerizable resin used by dentist or dental technician for the CAD/CAM manufacturing of indirect restorative for both anterior and posterior restorations, including dcclusal surfaces, such as temporary or permanent crowns and bridges, inlays, onlays, and veneers. Methacrylate based resin is well known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical and biocompatible properties. The TERA HARZ II is made by Methacrylate-based resins. It has stored in a black 1,000g of HDPE bottle. It contains materials with shade A1/A2/A3/B1/B2/B3/C1/C2/C3/D1/D2/D3/OM1/OM2/OM3/M4. This resin is a liquid photopolymer material that is polymerized by UV laser at 405~412nm. the resin can be used to create a customized artificial permanent tooth model with a 3d printer that is cured by ultraviolet light. The liquid UV curing resin is cured at a specific wavelength (395~405nm) by the photo-initiator contained in the resin. Curing in a 3D printer is related to the conditions of the printer equipment, and is typically 100um in layer thickness, and is output at a resolution of 40 to 90μm on the x, y axis. This device should use specific 3D Printer equipment using UV light source, and it is possible to produce three-dimensional printed matter by curing lamination step by step a thickness of 100μm. However, scanner, design software, 3D printer and post-cure unit are not included with the device. TERA HARZ II can be used in combination with all lasers and DLP based 3D printers which support dental materials. TERA HARZ II is a resin for the generative production of longterm temporary dental restorations based on image projection systems (405-412 nm). The formulation of TERA HARZ II is optimized for the requirements of a robust production guaranteeing constant high quality. The TERA HARZ II is successfully tested for biocompatibility, certainly meets all mechanical and application demands. The material is used in a 3D printer, which prints the shape determined by a 3D stereo-lithographic drawing. The material can be used for build processes with layer thicknesses from 25 up to 100 um. After printing, the printed product is recommended to use a UV-light curing for final polymerization. These fabrications of TERA HARZ II are beginning with the dental clinician prescribing indirect restorative to treat a patient's both anterior restorations, including occlusal surfaces, and decision to use methacrylate-based resins is made by the dental clinician. TERA HARZ II, a permanent or temporary restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations, is manufactured in a 3D printer that is compatible. The dental clinician can generate a digital file by scanning the patient's mouth directly using approved Intraoral scanner software. This digital file is a series of CAD files (.stl) for building models that can be used to fabricate permanent or temporary restorations. Commonly used standard dental software is used by dental professionals to virtually design a restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The design software used is 3D Scanner by 3Shape A/S (510(K) Exempt). The specialized prosthetic treatment planning software has a establishment registration for the intended use under FDA Classification Product Code NOF, regulation 872.3661. This software is used for management of 3D scanned prosthetic models, prosthetic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned prosthetic models, virtual planning of prosthetic treatments by simulating tooth movements, and design of permanent or temporary restorations based on 3D scanned prosthetic models. Once dental clinic manufacturing unit receive the data that * .stl CAD files of crown and bridge the 3D printer begins additive manufacturing. The dental clinician (e.g., dentist) generates sequential 3D printed models replicating the approved treatment plan. The permanent or temporary restorations is 3D printed and cured in a post-curing unit. The fabricated permanent or temporary restorations are cut to fit dentition, the cleaned and polished to remove rough edges by the dental clinician. The prescribing physician review and approves the permanent or temporary restorations are provides them to the patient the confirming fit and design.

TERA HARZ CLEAR is intended for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars). Utilizing a series of increments, it sequentially positions teeth by way of continuous gentle force. TERA HARZ CLEAR is intended exclusively for professional dental work. Fabrication of aligner with TERA HARZ CLEAR requires an additive manufacturing system (AMS) that includes compatible with the following: Design: Scanner: 3Shape A/S, TRIOS 3 Basic Design software: 3Shape A/S, 3Shape Ortho System™ Printing: 3D Printer: UNIZ, SLASH 2; SprintRay Inc., SprintRay Pro 95 Post-Curing: Post-cure unit: CureM, U102H

TERA HARZ CLEAR is a series of clear aligners that are used to replace traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligner is intended for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars) by moves the teeth gently, and in small increments, from their original to their final treated position for improved dental alignment. This series of aligner is worn for approximately 1 week of 20 to 22 hours per day after (However, there are to be removed for eating and for cleaning) which it is replaced by the next stage aligners and are designed to be used in a sequence. This is repeated for duration as prescribed by the dental clinician. TERA HARZ CLEAR is a light-cured, methacrylate-based resin commonly can used in additive manufacturing for the production of dental structures such as sequential aligners. TERA HARZ CLEAR has stored in a black 1,000 g of HDPE bottle. It contains materials with colors of yellowish. This device is a liquid photo-curable material that is polymerized by UV laser at 405~412 nm. It can be used to make a tooth model with a photo-curable polymer that is cured by ultraviolet light. The liquid UV curing resin is cured at a specific wavelength (395~405 nm) by the photo-initiator contained in the resin. It is typically 100 um in thickness and is output at a resolution of 40 to 90 µm on the x, y axis, and it is possible to produce three-dimensional printed matter by curing lamination step by step a thickness of 100 um. However, scanner, design software, 3D printer and post-cure unit are not included with the device. These fabrications of TERA HARZ CLEAR are beginning with the dental clinician prescribing aligners to treat a patient's malocclusion, and decision to use methacrylatebased resins is made by the dental clinician. TERA HARZ CLEAR, an orthodontic appliance such as sequential aligner, is manufactured in a 3D printer that is compatible. The dental clinician can generate a digital file by scanning the patient's mouth directly using listed with Intraoral scanner under FDA Classification Product Code NOF, regulation 872.3661. This digital file is a series of CAD files (.stl) for building models that can be used to fabricate aligners. Commonly used standard dental software is used by dental professionals to virtually design a sequential aligner and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The design software used is 3Shape Ortho System™ by 3Shape A/S (K180941). The specialized orthodontic treatment planning software has a 510k clearance for the intended use under FDA Classification Product Code PNN, regulation 872.5470. This software is used for management of 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, and design of sequential aligners based on 3D scanned orthodontic models. Once dental clinic manufacturing unit receive the data that *.stl CAD files of the treatment plan the 3D printer begins additive manufacturing. The dental clinician generates sequential 3D printed models replicating the approved treatment plan. The sequential aligner is 3D printed and cured in a post-cure unit. The fabricated aligners are cut to fit dentition, the cleaned and polished to remove rough edges by the dental clinician. The prescribing physician review and approves the sequential aligners are provides them to the patient the confirming fit and design.

The TERA HARZ DENTURE is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with the TERA HARZ DENTURE requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on digital impression, stereolithographic additive printer, and curing light equipment.

The TERA HARZ DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing dental structures (both full and partial dentures). Methacrylate-based resin is a known material that is often used in the dental industry for fixed and removable prosthetic devices due to its physical-chemical, and biocompatible properties. The TERA HARZ DENTURE is made from methacrylate-based resins. It is stored in a black 1,000g HDPE bottle. This resin is a liquid photopolymer material that is polymerized by a ultraviolet (UV) laser at 405~412 nm. The resin can be used to create customized removable full and partial dentures with a 3D printer cured by UV light. The UV curable liquid resin is cured at a specific wavelength (395~405 nm) by the photo-initiator contained in the resin. The process parameters of the 3D printer affect the quality of the 3D printed objects. The printer equipment should be set to a resolution of 40 to 90 um on the x,y axis (horizontal resolution) and 100 µm on the z axis (vertical resolution). The TERA HARZ DENTURE should be used with a specific 3D printer that uses a UV light source and produces 3D printed objects with layer thickness of 100 um. The TERA HARZ DENTURE does not come with a scanner, design software, 3D printer, or post-cure unit. The TERA HARZ DENTURE can be used to manufacture customized removable full and partial dentures using compatible equipment.

TERA HARZ is indicated as an indirect restorative for both anterior restorations, including occlusal surfaces. The TERA HARZ material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.

The TERA HARZ is a light-cured, methacrylate oligomer based polymerizable resin used by dentist or dental technician for the CAD/CAM manufacturing of indirect restorative for both anterior and posterior restorations, including occlusal surfaces, such as temporary or permanent crowns and bridges, inlays, onlays and veneers. Methacrylate based resin is known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical and biocompatible properties. The TERA HARZ is made by Methacrylate-based resins. It has stored in a black 1,000g of HDPE bottle. It contains materials with shade A1/A2/A3. This resin is a liquid photopolymer material that is polymerized by UV laser at 405~412nm. the resin can be used to create a customized artificial permanent tooth model with a 3d printer that is cured by ultraviolet light. The liquid UV curing resin is cured at a specific wavelength (395~405nm) by the photo-initiator contained in the resin. Curing in a 3D printer is related to the conditions of the printer equipment, and is typically 100μm in layer thickness, and is output at a resolution of 40 to 90μm on the x, y axis. This device should use specific 3D Printer equipment using UV light source, and it is possible to produce three-dimensional printed matter by curing lamination step by step a thickness of 100μm. However, scanner, design software, 3D printer and post-cure unit are not included with the device. TERA HARZ can be used in combination with specified lasers and DLP based 3D printers which support dental materials. TERA HARZ is a resin for the generative production of permanent or temporary dental restorations based on image projection systems (405-412 nm). The formulation of TERA HARZ is optimized for the requirements of a robust production guaranteeing constant high quality. The TERA HARZ is successfully tested for biocompatibility, certainly meets all mechanical and application demands. The material is used in a 3D printer, which prints the shape determined by a 3D stereolithographic drawing. The material can be used for build processes with layer thicknesses from 25 up to 100 um. After printing, the printed product is recommended to use a UV-light curing for final polymerization. 3D printer is not included with the device. These fabrications of TERA HARZ are beginning with the dental clinician prescribing indirect restorative to treat a patient's both anterior restorations, including occlusal surfaces, and decision to use methacrylate-based resins is made by the dental clinician. TERA HARZ, a permanent or temporary restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations, is manufactured in a 3D printer that is compatible. The dental clinician can generate a digital file by scanning the patient's mouth directly using approved Intraoral scanner software. This digital file is a series of CAD files (.stl) for building models that can be used to fabricate permanent or temporary restorations. Commonly used standard dental software is used by dental professionals to virtually design a restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The design software used is 3D Scanner by 3Shape A/S (510(K) Exempt). The specialized prosthetic treatment planning software has a establishment registration for the intended use under FDA Classification Product Code NOF, regulation 872.3661. This software is used for management of 3D scanned prosthetic models, prosthetic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned prosthetic models, virtual planning of prosthetic treatments by simulating tooth movements, and design of permanent or temporary restorations based on 3D scanned prosthetic models. Once dental clinic manufacturing unit receive the data that *.stl CAD files of crown and bridge the 3D printer begins additive manufacturing. The dental clinician (e.g., dentist) generates sequential 3D printed models replicating the approved treatment plan. The permanent or temporary restorations is 3D printed and cured in a post-curing unit. The fabricated permanent or temporary restorations are cut to fit dentition, the cleaned and polished to remove rough edges by the dental clinician. The prescribing physician review and approves the permanent or temporary restorations are provides them to the patient the confirming fit and design.