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The BTI Interna Dental Implant System UnicCa® - Prosthetic Components are intended to function in the mandible or maxilla to support single and multiple-unit temporary or definitive restorations on the BTI Interna® Dental Implant System.

The purpose of this 510(k) is to obtain marketing clearance for expanding the catalogue of abutments and prosthetic components for the Universal Plus and Wide platform of the BTI Interna® Dental Implant System. The premarket notification includes a set of different abutments and screws: UNIT transepithelial abutments, Aesthetic Interfaces, Square Aesthetic Abutments, Angled Titanium Abutments and MULTI-IM transepithelial abutment screws compatible with the cited previous platforms of the BTI Implant System Unicca® in its internal engaging connection version. The implant to abutment connection of all set of abutments range from 4.1mm to 5.5mm. All subject devices are provided sterile via Gamma Radiation. All abutment configurations are not to be used with compatible BTI Interna implant bodies placed at angle (no angular correction), with the exception of the subject Angled Titanium Abutments. The subject device Transepithelial abutments are straight abutments designed for single (UNIT) and multiple (MULTI-IM) screw-retained restorations. These transepithelial abutments are provided in a range of gingival height from 1.0mm to 4.0mm. All designs have a prosthetic diameter of 5.5mm. Aesthetic Interfaces are the compatible attachments used to support definitive restorations over transepithelial abutments. Two models are available: Square Aesthetic Interfaces used in single restorations and Aesthetic Interfaces for multiple restorations. Square Aesthetic Interfaces are characterized by an engaging connection to UNIT transepithelial abutments and by four anti rotation lobes placed in prosthetic parts. Aesthetic Interfaces has a conical design with a non-engaging connection to MULTI-IM transepithelial abutments. Prosthetic diameter of aesthetic interfaces can be 5.5mm or 6.5mm, and prosthetic height, 3.5mm or 4.2mm. Aesthetic Interfaces are attached to the transepithelial abutments with their specific retention screws, MULTI-IM transepithelial abutments screws. The proposed device Square Aesthetic Abutments are straight abutments design for single and multiple restorations in screwed or cemented restorations via traditional casting techniques. The engaging /non-engaging implant abutment connection has a diameter of 4.1mm or 5.5mm, depending on the compatibility with the implant. Square Aesthetic abutments are available in a range of gingival heights from 0.5 to 3.5mm. Angled Titanium Abutments are premanufactured abutments directly used into the implant in single and multiple cemented restorations. These devices compensate up to 15° misalignment of implants between implant axis and prosthesis axis. Angled Titanium abutments are available in two gingival heights (2 or 4mm) and are compatible with Wide Implant Platform. All abutments and interfaces are made of unalloyed conforming to ASTM F67 and are coated with titanium nitride (TiN). MULTI-IM transepithelial screws are manufactured in titanium alloy in accordance with ASTM F136, and the surface of the screw thread is coated with tungsten carbide/carbon and chromium (WC/C).

The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function. In the case of 5.5 - 6.5mm long UnicCa® implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations. In the case of Tiny® 3.0 UnicCa® implants: These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.

BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant provided in two types of connections: external (i.e., Externa®) and interna®), in a variety of platforms and range of diameters (3.0 – 6.0 mm) and lengths (5.5 – 18.0 mm). BTI Dental Implant System UnicCa® features an implant surface treatment that improves the hydrophilicity of the implant. The purpose of this 510(k) is to expand the product offering and include a new dental implant platform (Interna Narrow), and compatible abutments, together with additional implants for the already existing Universal Plus platform. Interna Narrow implants will be offered with implant diameters ranging from 3.3 to 4.75 mm and lengths of 5.5 to 15 mm. Additionally, new implants for the existing Universal Plus platform of diameter 6.0 mm, and lengths of 7.5 to 11.5 mm are included.