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Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit and/or multi-unit restorations. When a one-stage surgical approach is applied, the Implacil Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The Maestro line of Implacil Implant System is composed of three implant-to-abutment connections which are External Hex (HE), Internal Hex (HI) and Morse Taper AR Due Cone (CM AR). All of them are bone-level implants. The implants subject of this submission are threaded, self-tapping, root form endosseous dental implants used to support single or multiple restorations in immediate or conventional loading protocols. The subject devices are recommended for all bone density types, depending on the drill sequence used. The implants are made of commercially pure titanium (Grade 4) conforming to ASTM F67 and are surface treated to create a rough surface using an abrasive particle jet concept with controlled grain oxides, followed by acid etching creating uniform cavities in the implant surface. The Maestro implant line has radial channels (55 °) or chambers on their external surface.

Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit and/or multi-unit restorations. When a one-stage surgical is applied, the Implacil Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Implacil Implant System is composed of three implant lines that are divided according to the implant-toabutment interface: External Hex (HE), Internal Hex (HI) and Morse Taper AR Due Cone (CM AR). HE and HI lines are composed of tissue-level implants while CM AR line of bone-level implants. Each implant line is composed of implants and related prosthetic components available in multiple designs (temporary, screwed, cementable, angled, straight, UCLA, ball). HE implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm). Cylindrical implants are provided in four diameters (3.3, 3.75, 4.0 and 4.75 mm), three platforms (3.5, 4.0 and 5.0 mm) and five lengths (8.0, 10.0, 11.5, 13.0 and 15.0 mm). HE cylindrical implants of diameters 3.75 and 4.0 share the same platform of 4.0 mm. HI implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm). For diameters 3.5 and 4.0 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 5.0 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. Cylindrical implants are provided in four diameters (3.3, 3.75, 4.3 and 4.75 mm) and three platforms (3.5, 4.0 and 5.0 mm). For diameter 3.3 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 3.75 and 4.3 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. HI cylindrical implants of diameters 3.75 and 4.3 share the same platform of 4.0 mm. CM AR implant line implants are available in conical root-form design only, in four diameters (3.5, 4.0, 4.5 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm). lmplacil implants are made of commercially pure titanium (ASTM F67). Implacil prosthetic components are made of commercially pure titanium (ASTM F67) or titanium alloy (ASTM F136). Implant System screws (abutment screw, UCLA screws and coping screws) are made of titanium alloy (ASTM F136). The subject device abutments components mate exclusively with the subject implants of the same line (HJ, HE, CM AR).