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DenTack PYRAMIDION Dental Implants and Prostheses are intended for surgical placement in the maxilla and/or in the mandible to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous jaws utilizing conventional, delayed or immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants in 5-6mm length are indicated for delayed loading only.

DenTack has developed a range of expandable dental implants made of titanium (the most common material for dental implants) to serve the need of patients that require partial or complete tooth restoration. The implant is placed so its end is in the trabecular (spongy) bone like any other implant. Once in place, the apical portion of the implant is expanded to achieve increased contact surface area with the surrounding bone. The system also includes various accessories that are attached to the implant. The PYRAMIDION has an external hex connection with 0.7mm height and 2.7mm hex with a distinct projection externally to the implant body. The connection between the prosthetic part to the upper platform of the implant interacts with a recessed plain of 15-degrees into the upper platform of the implant body while it is projected from the prosthetic part. All DenTack's implants are made of biocompatible Titanium. Prostheses and Surgical components are made of same Titanium alloy, stainless-steel and polymers. DenTack's PYRAMIDION Implants with are the subject of this submission are available in outer diameter (OD) of 4.1 mm and in length of 5 and 6 mm. DenTack's Prostheses and dimension ranges are identified as follows: Metal Housing: 3.3 mm Height Plastic Cup: 2.7 mm Height Straight Multi-Unit Sleeve: 11 mm Height Straight Multi-Unit Screw: 2.3 mm Diameter Angled Abutments 15° And 22.5°: Length: 7 mm – 9 mm Angled Abutments 15° Large: Total Length: 9 mm – 12 mm Ball Attachments: 2, 3 and 4 mm Height Direct Screw Platform Straight Abutments 2, 3, 8.5 mm Length Straight Multi-Unit Abutments 2, 3 and 4 mm Length Angled Multi Unit Abutments 17° and 1.5 and 3 mm Length Healing Caps 3, 4, 5 and 6 mm Cover Screw The Direct Screw Platform is to be used with a burn-out plastic sleeve for ensuring a minimum post height of 4 mm (with no angular correction). Like the QUAD implants cleared under K152188, the subject PYRAMIDION implants expansion is performed using a reusable Expansion Tool and Ratchet Torque).