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Implants: The ASTRA TECH Implant System - OsseoSpeed Profile EV implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: · replacing missing teeth in single or multiple unit applications in the mandible or maxilla. - · immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge - · especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective - · immediate and early loading for all indications - · together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate - · only together with Profile EV components, Implant Driver Profile EV, Radiographic Implant Guides Profile EV and non-Indexed prosthetic components Abutments ASTRA TECH Implant System™ - OsseoSpeed™ EV abutments are intended to be used in conjunction with ASTRA TECH Implant System™ - OsseoSpeed™ EV in fully edentulous or partially edentulous maxillary and/or mandibular arches. The ATLANTIS™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The ATLANTIS™ Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant. The ATLANTIS™ Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS™ Abutment to the endosseous implant. ATLANTIS™ Abutment, ATLANTIS™ Crown Abutment and ATLANTIS™ Conus Abutment are compatible with ASTRA TECH Implant System Profile EV.

The purpose of this submission is to expand the current OsseoSpeed EV Implant System (previously named OsseoSpeed Plus) to include the OsseoSpeed Profile EV implants. The OsseoSpeed EV Implant line is a part of the ASTRA TECH Implant System. The coronal contour of the OsseoSpeed Profile EV implant is designed to follow the anatomical contour of the bone and facilitate a more esthetic restoration. Implants are available in a straight (cylindrical) design or with a taper at the implant neck. Each design is provided in two diameters (4.2 and 4.8 mm) and six lengths (8, 9, 11, 13, 15, and 17 mm). Abutments are provided in titanium allov and zirconia materials. Abutments have platform diameters of 3.0, 4.2, and 4.8 mm, prosthetic diameters from 3.3 to 7.0 mm, and gingival heights ranging from 2.0 to 6.5 mm. Abutments are provided straight and with up to 30° of angulation.