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The K3Pro® Konus New Abutments and Implants are designed to be compatible with the K3Pro® Konus Dental Implant system and are for use in edentulous sites in the maxilla for support of a complete denture prosthesis, a final or intermediate abutment for fixed bridgework or for partial dentures, or as a single tooth replacement. Delayed loading is recommended. The Ø7, 8, and 9mm implants are intended only for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications. All digitally designed abutments for use with K3Pro® New Abutments and Implants are intended to be sent to an Argon validated milling center for manufacture.

The K3Pro® Konus New Abutments and Implants are components of the K3Pro® Konus Dental Implant System. The submission includes new implant bodies (7.0mm and 8.0mm diameter, 3.0mm platform, 8.0 to 11.0mm length) made of Grade 4 titanium with Osteo-Active™ surface treatment, and additional Ti-Base abutments (KSA, CG.V, and CS) in 2.0mm and 3.0mm platform diameters made of Grade 5 Ti-6Al 4V-ELI. The abutments are designed to fit and function only on previously cleared K3Pro® Konus Dental Implants (K141159, K160581) and the implants submitted in this submission. They have the same Konus connection and are screw retained. Abutment screws are made of Grade 4 titanium. All devices are for single use only. Digitally designed abutments are intended for fabrication of patient-specific abutments using FDA cleared CAD/CAM technology and manufactured by an Argon Medical Productions validated milling center. Zirconium coping and/or crown for Ti-Base abutments are made of ZrO2 and luted with an FDA cleared cement.

K3Pro Konus Additional Abutments and Implants are designed to be compatible with the K3Pro Konus Dental Implant system and are for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a final or intermediate abutment for fixed bridgework or for partial dentures, or as a single tooth replacement. Delayed loading is recommended. The prosthesis may be secured to the abutment by the use of adhesives or mechanically by the use of a screw.

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The Konus K3Pro and K3Pro Rapid Implant is designed for use in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or as a single tooth replacement. The Konus K3Pro and K3Pro Rapid Implant is designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or for partial dentures, or as a single tooth replacement.

The K3Pro Konus Dental Implant System include endosseous Rapid and Sure root form and threaded, tapered and straight implants, they come in a range of diameter sizes 3.0 mm to 6.0 mm and range in length from 7.5 mm to 17 mm. Cover screws, healing caps, straight and angled dental implant abutments with threaded abutment connection having a Morse style taper. With a range of 0° to 30 ° angle. Abutment screws, temporary abutments, ball abutments, in a variety of diameters and heights to accommodate differing patient anatomy. The implants are manufactured from pure, implant-grade 4 titanium. The abutments are manufactured from Grade 5 Ti-6A1 4V-ELI. The internal connection has a 2 mm mini connection with a Konus connection with a 3° taper with a hexagonal orientation. The Standard has a 3 mm Konus connection with a 3° taper with a hexagonal orientation. Cover screws and healing caps provide protection to the threads of the abutment connection during endosseous and gingival healing. Cover screws are pre-packaged with each implant. Healing caps are provided as an alternative to the cover screw and are packaged separately.