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TiXos dental implants are permanent devices for single use only that are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches of the patient in order to restore their original dental function and aesthetic features by providing support for fixed and/or removal prosthesis. TiXos dental implants can support single tooth, multiple tooth, or total prosthesis restorations and are compatible with the following dental abutments manufactured by Leader Italia that were previously cleared under K062931.

Leader Italia's line of TiXos dental implants are titanium endosseous implants that are fabricated by a process called Direct Laser Metal Forming ("DLMF"). This fabrication process results in the production of an implant with a porous surface characterized by open intercommunicating cavities and networks. The implants are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches of the patient to provide support to be their fixed and/or removal prosthesis, and to restore their original dental and/or masticatory function. TiXos dental implants are permanent devices for single use and can support single tooth, multiple tooth, or total prosthesis restorations. These implants are designed to be used exclusively with Leader Italia's line of prosthetic abutments and surgical instruments. TiXos dental implants are gamma sterilized, have two basic model configurations called Cylindrical and S-Type, and a number of different sizes and diameters as shown below.

IMPLUS implant fixtures are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches in order to provide support for fixed and/or removal prosthetics in order to restore original features and masticatory functions. Implus implant fixtures are indicated for permanent use. Implus implant fixtures are disposable and are for one-time use only. These fixtures are not to be recleaned or re-sterilized.

Leader Italia IMPLUS implants are available in cylindrical or tapered shape, with different dimensions; connection to abutments is made by internal or external hexagon. All implants are manufactured from medical titanium in grade 4 (Ref. ASTM F67) with a modified surface for optimum ostheointegration. The implants are all provided sterile in a packaging complete with mount transfer.