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K3 is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants.

K3, Dental Unit and Chair, is designed for dental treatment of children and adults. It is a dental treatment unit in accordance with ISO 7494-1, ISO 7494-2 and ISO 6875. The 3way syringe is a dental instrument in accordance with EN 1639. It aids the dental application in the mouth of the patient by supplying air, water or spray. This product is designed for use in dentistry only and may only be used by trained medical personnel K3 is similar to other commercially available products based on the intended use, the technology used, the claims, the electrical power and performance characteristics. It is substantially equivalent in design, function and intended use to the predicate devices.

The US SA Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restorations such as bridges, or overdenture.

The US SA Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. The US Multi Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration.

The Portable X-ray system (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.

EXARO, Xray2GO, a portable dental X-ray system, operates on 25.2V DC supplied by a rechargeable Li-Polymer battery pack, The X-ray tube head, controls and power source are assembled into a single hand-held enclosure. The package includes a battery charger. The potable X-ray system, EXARO, Xray2GO, being composed of X-ray generator, controller, and beam limiting device is designed to diagnose tooth and jaw through generated and controlled X-ray. The operating principle of EXARO, Xray2GO starts from the generation of X-ray by high voltage electricity, which in turn penetrates tooth and jaw area after flowing through X-ray tube and produces X-ray images on X-ray receptors (i.e. chemical film or digital sensor) This device contains a high frequency inverter that converts direct to alternating current. X-ray tube head, electrical protective devices, and other elements. The EXARO, Xray2GO produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.

ET Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

The ET Prosthetic System is device made of titanium and titanium alloy intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment Screws. It's surfaces are partially TiN coated and uncoated. The ET Prosthetic System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The ET Prosthetic System is substantially equivalent in design, function and intended use to the Prosthetic System(K110308) and ET/SS Implant System (K120847)of Osstem Implant Co., Ltd. These proposed abutments are compatible with the HIOSSEN Implant fixture only. HTIII SA Fixture (K101096).

SMARTbuilder System is a metal (Non-resorbable membrane) device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.

Customized 3D Pre-Formed Titanium Membrane. SMARTbuilder System (SB1) is the nonabsorbable membrane that is made of titanium metal to stabilize and support of bone graft after bone transplantation at the area having autogenous bone deficiency in the oral cavity. The SMARTbuilder System (SB1) is made of pure titanium metal and supplied sterile.

The Portable X-ray System(Model:EXARO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.

EXARO, a portable dental X-ray system, operates on 25.2V DC supplied by a rechargeable Li-Polymer battery pack, The X-ray tubehead, controls and power source are assembled into a single hand-held enclosure. The package includes a battery charger. The potable X-ray system, EXARO, being composed of X-ray generator, controller, and beam limiting device is designed to diagnose tooth and jaw through generated and controlled X-ray. The mechanical principle of EXARO starts from the generation of X-ray by high voltage electricity, which in turn penetrates tooth and jaw area after flowing through X-ray tube and produces X-ray images on X-ray receptors (i.e. chemical film or digital sensor). This device contains a high frequency inverter that converts direct to alternating current, X-ray tubehead, electrical protective devices, and other elements. The EXARO produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.

The TS Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restorations such as crowns, bridges, or overdenture.

The TS Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. Abutment is device made of titanium alloy and Plastic and it is intended for use to make temporary prosthesis. It consists of Abutment and Abutment Screw.

NP-Cast Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

NP-Cast Abutment System is used for prosthetic restoration. It is used for cases with path and aesthetic and spatial constraints. After customization, be sure to use only dental nonprecious metal (Co-Cr-Mo alloy) for casting to make the prosthesis When cast a prosthesis with NP-Cast Abutment System, Post height above the transmucosal collar of NP-Cast Abutment System has to be taller than 4mm and Maxmimum angulation has to be less than 30°. The NP-Cast Abutment System consists of Abutment and Abutment Screws.

The TS Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. TS Fixture System is compatible with abutment in the ET/SS Implant System

The TS Fixture System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is available in various lengths 7.0 to 15.0mm and diameters 3.5 to 6.8mm (TSII SA Fixture : 3.5, 4.2, 4.4, 4.9 / TSIII SA Fixture: 3.75, 3.77, 4.2, 4.25, 4.6, 4.63, 4.65, 5.05, 5.08, 5.1 / TSIII SA Ultra-Wide Fixture : 5.92, 5.95, 6, 6.8) according to the anatomical situation. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. The TS Fixture System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

SMARTbuilder System is a metal (Non-resorbable membrane) device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.

Customized 3D Pre-Formed Titanium Membrane. SMARTBuilder is the non-absorbable membrane that is made of titanium metal to stabilize and support of bone graft after bone transplantation at the area having autogenous bone deficiency in the oral cavity. The SMARTbuilder is made of pure titanium metal and supplied sterile. The SMARTbuilder system is used with GS3 System (K091208) of OSSTEM Implant Co., Ltd. and US.SS.GS System (K073247) of OSSTEM Implant Co., Ltd.