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ZENEX Implant System Long is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. ZENEX Implants in the 20 mm length when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

ZENEX Implant System_Long is a thread type implant made of pure titanium according to ASTM F 67 and supplied sterile, which will be placed in the alveolar bone in order to support or maintain the prosthetic tooth or denture when a patient's teeth are partially or totally lost. The fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). There are 2 types of fixtures, and the dimensions are as following: | Name | Fixture Type | Diameter (mm) | Length (mm) | Material | |----------------------------------------------------------|-----------------------|---------------|-------------|----------| | ZENEX Implant<br>System_Long<br>(ZENEX MULTI<br>Fixture) | Image: Fixture Type 1 | Ø 3.75/4.25 | 18mm/20mm | | | | Ø 4.6 | 18mm | | | | ZENEX Implant<br>System_Long<br>(ZENEX PLUS<br>Fixture) | Image: Fixture Type 2 | Ø 3.75/4.25 | 18mm/20mm | | | | | Ø 4.6 | 18mm | | The subject devices are compatible with the following abutments made by Izenimplant Co., Ltd. ZENEX Implant System_Long is provided sterile, and valid for 5 years.

Ti Link Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. All digitally designed abutments for use with Ti Link Abutment are intended to be manufactured at a Izenimplant validated milling center.

The Ti Link Abutment is a two-piece abutment intended to provide support for restorations such as crowns and bridges. The two pieces which compose the final abutment consist of the pre-manufactured titanium base component composed of titanium alloy conforming to ASTM F136, and the CAD/CAM patient matched mesostructure composed of zirconia (K091096). The diameters of the premanufactured titanium base component are 4.0/4.5mm. The final two-piece abutment is fixed to the implant with an abutment screw composed of titanium alloy conforming to ASTM F136. Ti Link Abutment is provided non-sterile, therefore must be sterilized after the cementation of the CAD/CAM patient matched mesostructure on the pre-manufactured titanium base component. The abutments are compatible with the implants cleared under K211090. The CAD/CAM patient matched mesostructure that is added to the pre-manufactured titanium base component to create the final abutment design should be designed and milled through the CAD/CAM software, according to the prosthetic planning and patient clinical situation. The coping and crowns designed using these or more recent versions of the CAD/CAM System, within the design limits as defined within the design software, are compatible with the Ti Link Abutment. The coping would be manufactured by Izenimplant only with design input using CAD/CAM Software from and by Izenimplant milling center. CAD/CAM patient matched mesostructure is made from NaturaZ (K091096) and is cemented to the pre-manufactured titanium base component using RelyX cement (K110508) to complete the final finished abutment.

The ZENEX Implant System_Short 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. ZENEX Implant System Short are intended to be used in the molar region.

ZENEX Implant System_Short is a thread type implant made of pure titanium according to ASTM F 67 and supplied sterile, which will be placed in the alveolar bone in order to support or maintain the prosthetic tooth or denture when a patient's teeth are partially or totally lost. The fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). The entire length of 6.25mm of implant bodies are implanted into the bone to connect prosthetic devices of a dental implant set with the human body (mandibular or maxillary bone).

The ZENEX FreeMilling & CCM Cast Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

ZENEX FreeMilling & CCM Cast Abutment consists of FreeMilling Abutment and CCM Cast Abutment. ZENEX FreeMilling & CCM Cast Abutment is compatible with the fixtures below: K number: K211090 Device Name: ZENEX Implant System (ZENEX MULTI&PLUS Fixture) Dimension Ranges: Diameter 3.75 x 8.5, 10, 11.5, 13, 15; Diameter 4.25 x 7, 8.5, 10, 11.5, 13, 15; Diameter 4.6 x 7, 8.5, 10, 11.5, 13, 15; Diameter 5.05 x 7, 8.5, 10, 11.5, 13, 15; Diameter 5.4 x 7, 8.5, 10, 11.5, 13; Diameter 5.9 x 7, 8.5, 10, 11.5, 13; Diameter 6.75 x 7, 8.5, 10, 11.5, 13 Tolerance of dimension shall be within ± 1% range. The dimensions of abutments are as following: Device Name: FreeMilling Abutment Dimension Ranges: Diameter 4.0/4.5/5.0/5.2/5.7/6.0/6.5/7.0 Gingival Heights (mm): 1.3/1.8/2.8/3.8 Minimum Post height (mm): 4 Angulation: 0° Device Name: CCM Cast Abutment Dimension Ranges: Diameter 4.0 / 4.5 Gingival Heights (mm): 0.8 / 2.8 Minimum Post height (mm): 4 Angulation: 0° The Abutments have below featured: Name: FreeMilling Abutment Uses: The Abutment is connected with fixture, and it supports prosthesis which restores tooth function. Surface: Partial TiN coated in upper Connection: Screw retained Name: CCM Cast Abutment Uses: It is an abutment that is used when making a retained / customized prosthesis. Surface: NA Connection: Screw retained Tolerance of dimensions for Abutments shall be within ± 1% range. ZENEX FreeMilling & CCM Cast Abutment is provided non-sterile. Materials: - FreeMilling Abutment is fabricated of Ti-6Al-4V ELI according to ASTM F136-13 - CCM Cast Abutment is fabricated of Co-Cr-Mo according to ASTM F1537-11

The ZENEX Implant System Narrow (3.0, 3.2mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately 1) with a temporary prosthesis that is not in functional occlusion, 2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or 3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

The ZENEX Implant System Narrow consists of dental implants, and screws for use in one or two-stage dental implant placement and restorations. The fixtures and abutments in this system are: ZENEX MULTI Fixture, ZENEX PLUS Fixture, Cover Screw, Healing Abutment, Cemented Abutment (Hex, Non-Hex), Angled Abutment (Hex, Non-Hex), Temporary Abutment (Hex, Non-Hex), FreeMilling Abutment (Hex, Non-Hex), CCM Cast Abutment (Hex, Non-Hex), and Abutment Screw. An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the ZENEX MULTI and PLUS Fixtures are treated with SLA(sand-blasted, large-grit, acid-etched). The subject fixture, cover screw and healing abutment are provided sterile. Other abutments are provided non-sterile and packaged separately.

ZENEX 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. Wide Fixture System is intended to be used in the molar region

ZENEX Implant System is consisted with ZENEX Fixtures (ZENEX MULTI Fixture and ZENEX PLUS Fixture) and Izenimplant Abutment System. The implant fixtures come in two unique systems, the I-System and the T-System, each with their own abutment compatibilities. 1) ZENEX Fixtures: This product is a dental implant which is put into the alveolar bone in order to support, or maintain the prosthetic tooth or denture when a patient's teeth are partially lost. To enhance the osseointegration with the alveolar bone, this titanium dental implant is treated with SLA surface. As a dental implant which is put into the alveolar bone to support the dental prostheses such as the artificial teeth which are used to rehabilitate a patient's masticatory function, it is used as a substructure which is implanted into the human body. This product is a dental implant fixture to be inserted into the bone and is intended to be used in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations. It is connected to the upper structure with Internal Hex fastening structure. In the surface treatment, machined surface was sanded with alumina (Al2O3) powder and acid (hydrochloric acid, sulfuric acid) etching process was applied to the surface to increase the contact surface with the bone. ZENEX PLUS is a design that adds a micro-groove at the collar compared to ZENEX MULTI. 2) Izenimplant Abutment System: Izenimplant Abutment System is compatible with the ZENEX Fixtures (ZENEX MULTI Fixture, ZENEX PLUS Fixture). Izenimplant Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Separate sets of abutments are presented for compatibility with each I-System and T-System. Some subject abutments undergo Titanium Nitride (TiN) coating. Dental Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.