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ArgenZ MTZ zirconia can be used for the production of full-contour and substructure restorations up to and including a full arch. All blanks are processed by dental laboratories or by dental professionals.

The ArgenZ MTZ (referring to multi-translucent, multi-layer) zirconia consist of yttria-stabilized pre-shaded 4 mole and 5 mole percent zirconia. They are manufactured (pressed and sintered) into disc forms and offered multiple thicknesses and multiple shades. They contain oxides of Hafnium and Aluminum and minute amounts of coloring oxides of iron, erbium, cobalt and manganese. The discs are single use, non-sterile devices and used for fabricating dental restorations, using CAD/CAM systems that can accommodate the disc sizes.

The Argen Clear Aligner and Argen Clear Aligner Premium are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The aligner positions teeth by way of continuous gentle force.

The Argen clear aligners are comprised of series of clear plastic removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. A dental health professional (e.g. orthodontist or dentist) prescribes the Argen Clear Aligner or the Argen Clear Aligner Premium based on an assessment of the patient's teeth. The dental health professional (dentist/orthodontist) takes intraoral scans or physical impressions of the patient's teeth, determines a course of treatment with the system, and completes a prescription form using a standard dental software used for tooth alignment. The series of plastic trays are designed in accordance with the physician's prescription using standard dental software for planning the tooth alignment. The software system used is Ortho Analyzer, 2019 ver 1.8.1.0 by 3Shape A/S (K180941). It 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 orthodontic appliances based on 3D scanned orthodontic models. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Argen produces trays, which are formed of clear, thin, thermoformed plastic. The trays are provided to the dental health care professional who provides them to the patient, confirming fit and design. The thermoplastic materials used in the manufacture of the Argen aligners are similar to the materials commonly used in many dental and orthodontic appliances including clear aligners. The Argen Clear Aligner is made of a thermoplastic polyurethane resin and the Argen Clear Aligner Premium is made of a thermoplastic polyurethane-polyester composite resin.

The Argen Clear Aligner is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The aligner positions teeth by way of continuous gentle force.

The Argen Clear Aligner is comprised of a series of clear plastic removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. A dental health professional (e.g. orthodontist or dentist) prescribes the Argen Clear Aligner based on an assessment of the patient's teeth, determines a course of treatment with the system, and completes a prescription form using a standard dental software used for tooth alignment. The series of plastic trays are designed in accordance with the physician's prescription using standard dental software for planning the tooth alignment. The software system used is Ortho Analyzer, 2019 ver 1.8.1.0 by 3Shape A/S (K180941). It 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 orthodontic appliances based on 3D scanned orthodontic models. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Argen produces trays, which are formed of clear, thin, thermoformed plastic. The trays are provided to the dental health care professional who provides them to the patient, confirming fit and design. The thermoplastic material used in the manufacture of the Argen aligners is similar to the material commonly used in many dental and orthodontic appliances including clear aligners.

ArgenZ HT+ (high translucent plus) zirconia can be used for the production of full contour and substructures restorations up to a full arch.

ArgenZ HT+ is a pressed Yttria stabilized Zirconia with primary oxides of Hafnium and Aluminum with naturally occurring trace oxides used to produce various shades.

ArgenZ Liquids are intended to be used by trained dental technicians as an accessory for shading ArgenZ allzirconia, monolithic restorations for anterior and posterior dental prosthetics.

ArqenZ Zirconia Coloring Liguids are dilute aqueous solutions of transition and lanthanoid metal salts used in combination with ArgenZ Zirconia material (K071410 and K150919) to properly shade teeth. Elements, which may include (but are not limited to) Co, Cr, Er, Fe, Mn, Pr, Ni, Bi, and Nd are combined with water to result in the finished product.

ArgenIS Titanium Abutments are intended to be single use available by prescription only in the construction of dental restorations supported by the endosseous dental implant. The Argents Titanium Abutments are designed to specifically fit an individual patient's needs of the final restoration. All digitally designed abutments files are intended to be sent to Argen manufacturer for milling. The ArgenIS Titanium Abutments are compatible with the following implant systems: | Implant Brand Name | Platform | Manufacturer | Implant Trade Name | Implant<br>Line/Connection | Implant Diameter | |------------------------------------|---------------|------------------|------------------------------------|----------------------------|------------------------------------------------| | Hiossen ET III SA | 3.5mm | Hiossen | Hiossen Implant System | Internal Hex | 3.75, 3.77mm | | Hiossen ET III SA | 4.0/4.5/5.0mm | Hiossen | Hiossen Implant System | Internal Hex | 4.25, 4.65, 4.63,<br>4.6, 5.1, 5.08,<br>5.05mm | | Nobel Active Wide<br>Platform (WP) | 5.5mm | Nobel Biocare AB | Nobel Active Wide<br>Platform (WP) | Internal Hex | 5.5mm |

The ArgenIS Titanium Abutments are designed specifically for an individual patient and then milled from a titanium blank with a pre-milled interface correlating to a specific implant system. The titanium abutment may be designed with a maximum angulation of 30°. The abutment is then fixed with the use of a lab screw to a model containing the implant analog for final construction of the related prosthetic restoration. The ArgenIS Titanium Abutments are then intended to be fixed in the mouth with the prosthetic final screw. The ArgenIS Titanium Abutments are supplied with two package configurations. One includes two final screws and the abutment and another includes one final screw and one lab screw and the abutment. The final screw is used for fixing abutment to the endosseous implant body, and the lab screw is used for laboratory use during construction of related restoration to avoid any damage to the final prosthetic screw. The final prosthetic screw will be marked "final Screw". The final screw must be torqued on the endosseous implant body with the specific torque setting provided. The device is finalized at the Argen facility and provided to the dental laboratory in a final patient specific form. There are no accessories associated with the subject devices. Minimum and Maximum Gingival Height is 0.5mm - 6mm Minimum diameter at abutment/implant interface is 3.5mm to interface base Maximum length of abutment from abutment/implant interface is 12.5mm Minimum length of abutment post (length above abutment collar/gingival height) is 4.0mm Minimum wall thickness at abutment/implant interface is 0.65mm Maximal angle in relationship to the long axis of implant is 30° All digitally designed abutment files are intended to be sent to Argen manufacturer for milling. Argen is a registered contract manufacturer with a quality system under FDA QSR regulation.

ArgenIS Titanium Abutments are intended to be single use available by prescription only in the construction of dental restorations supported by the endosseous dental implant. The ArgenIs Titanium Abutments are designed to specifically fit an individual patient's needs of the final restoration. All digitally designed abutments files are intended to be sent to Argen manufacturer for milling. The ArgenIS Titanium Abutments are compatible with the following implant systems: | IMPLANT BRAND<br>NAME | PLATFORM | Manufacturer | Implant Trade<br>Name | Implant<br>Line/Connection | Implant<br>Diameter | |---------------------------------|-----------|--------------------------|---------------------------------------------------|--------------------------------------------------------------|------------------------------| | Nobel Biocare Replace<br>Select | 6.0mm | Nobel Biocare USA | Nobel Replace<br>Tapered<br>Conical<br>Connection | Nobel Replace<br>Internal Conical<br>Connection WP | 6.0mm | | Nobel Biocare Active | 3.5mm | Nobel Biocare AB | NobelActive<br>Internal<br>Connection<br>Implant | Nobel Active<br>Internal Conn.<br>RP and NP | 3.0, 3.5, 4.3,<br>5.0mm | | Nobel Biocare Active | 4.3/5.0mm | Nobel Biocare AB | NobelActive<br>Internal<br>Connection<br>Implant | Nobel Active<br>Internal Conn.<br>RP and NP | 3.0, 3.5, 4.3,<br>5.0mm | | Straumann Bone Level | 3.3mm | Straumann USA | Straumann<br>Bone Level<br>Tapered<br>Implants | Bone Level<br>Internal Conn.<br>NC | 3.3mm | | Straumann Bone Level | 4.1/4.8mm | Straumann USA | Straumann<br>Bone Level<br>Tapered<br>Implants | Bone Level<br>Internal Conn.<br>RC | 4.1, 4.8mm | | Straumann Synocta | 4.8mm | Institut Straumann<br>AG | Straumann<br>Dental Implant | Synocta Implant<br>Internal Conn.<br>4.8mm RN (Reg.<br>Neck) | 4.8, 6.5mm | | Straumann Synocta | 6.5mm | Institut Straumann<br>AG | Straumann<br>Dental Implant | Synocta Implant<br>Internal Conn.<br>6.5mm (Wide<br>Neck) | 4.8, 6.5mm | | Astra Tech OsseoSpeed | 3.5/4.0mm | Astra Tech AB | AstraTech<br>Implant<br>OsseoSpeed | OsseoSpeed<br>Internal Conical<br>Connection RP | 3.6, 4.2, 4.8mm | | Astra Tech OsseoSpeed | 4.5/5.0mm | Astra Tech AB | AstraTech<br>Implant<br>OsseoSpeed<br>Plus | OsseoSpeed Plus<br>Internal Conical<br>Connection RP | 3.0, 3.5, 4.0, 4.5,<br>5.0mm |

Argen IS Titanium Abutments are designed specifically for an Individual patient and then milled from a Titanium blank with a pre-milled interface correlating to a specific implant system. This abutment can be fixed in the laboratory model work containing the implant analog for final construction of the related prosthetic restoration. The Argen IS Titanium Abutments are then intended to be fixed in the mouth with the included prosthetic screw. The Argen IS Titanium Abutments are supplied with 2 screws (1) A Final Screw for fixing to the endosseuos Implant. (2) A lab screw for Laboratory use during construction of related restoration to avoid any damage to the final prosthetic screw will be marked "final Screw". The final screw must be torqued on the endosseuos Implant with the specific torque setting provided. The device is finalized at the Argen facility and provided to the dental laboratory in a final patient specific form. Minimum and Maximum Gingival Height is 0-6mm Minimum diameter at abutment/implant interface is 3.5mm to interface base Maximum length of abutment from abutment/implant interface is 12.5mm Minimum length of abutment post (length above the abutment collar/gingival height) is 4.0mm. Minimum wall thickness at abutment/implant interface is 0.65mm Maximal angle in relationship to the long axis of implant is 30° The available range of diameters and connection type is summarized on the table below:

ArgenIS patient specific abutments are intended to be single use available by prescription only to dental professionals (dental technicians and Dentists) in the construction of dental restorations supported by endosseous dental implants. The Argen Is Abutment is designed to specifically fit an individual patients needs in order to more naturally support the tissue, esthetics, and function of the final restoration. The ArgenIS Titanium Abutments are compatible with the following implant systems: | Implant Brand and Type | Implant Diameter | | | | |------------------------------|------------------|--|--|--| | Nobel Biocare Replace Select | 3.5mm | | | | | Nobel Biocare Replace Select | 4.3mm | | | | | Nobel Biocare Replace Select | 5.0mm | | | | | Biomet 3i Certain | 3.25mm | | | | | Biomet 3i Certain | 4.0mm | | | | | Biomet 3i Certain | 5.0mm | | | | | Straumann Tissue Level - RN | 3.3mm | | | | | Straumann Tissue Level - RN | 4.1mm | | | | | Straumann Tissue Level - RN | 4.8mm | | | | | Zimmer Tapered Screw-Vent | 3.7mm | | | | | Zimmer Tapered Screw-Vent | 4.1mm | | | | | Zimmer Tapered Screw-Vent | 4.7mm | | | | | Zimmer Tapered Screw-Vent | 6.0mm | | | |

Argen IS Abutments are designed specifically for an Individual patient and then milled from a Titanium blank with a pre-milled interface correlating to a specific implant system. This abutment can be fixed in the laboratory model work containing the implant analog for final construction of the related prosthetic restoration. The Argen IS Abutment is then intended to be fixed in the mouth with the included prosthetic screw. The Argen IS Abutment is supplied with 2 screws (1) A Final Screw for fixing to the endosseuos Implant. (2) A lab screw for Laboratory use during construction of related restoration to avoid any damage to the final prosthetic screw. The final prosthetic screw will be marked "final Screw". The final screw must be torqued on the endosseuos Implant with the specific torque setting provided. The device is finalized at the Argen facility and provided to the dental laboratory in a final patient-specific form. Minimum and Maximum Gingival Height is 0-6mm Minimum diameter at abutment/implant interface is 3.5mm to interface base Maximum length of abutment from abutment/implant interface is 12.5mm Minimum length of abutment post (length above the abutment collar/gingival height) is 4.0mm Minimum wall thickness at abutment/implant interface is 0.65mm Maximal angle in relationship to the long axis of implant is 30° The proposed ArgenIS Titanium Abutments are available in a range of diameters and connection type.

ArgenZ Esthetic Plus blanks are intended to be used in the fabrication of inlays, crowns, copings, and fixed bridges (up to 3 units) using various CAD/CAM systems.

ArgenZ Esthetic Plus is a pressed Yttria stabilized Zirconia with oxides of Hafnium and Aluminum and an organic binder.

ARGEN PMMA Discs are polymethylmethacrylate blanks for dental use. These blanks are used to mill long-term temporary substructures for crowns & bridgework. The blanks are intended to be used in various CAD/CAM systems.

Polymethylmethacrylate (PMMA) discs or blanks for use in dental CAD/CAM systems.