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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.

This is a medical device 510(k) summary for the K3Pro Konus Dental Implant System. It describes the device, its intended use, and how it demonstrates substantial equivalence to predicate devices. However, the document does not contain details about acceptance criteria or a study proving the device meets specific performance criteria in terms of accuracy or clinical effectiveness with regards to AI performance characteristics.

The document states:

• Non-Clinical Testing: "Non-clinical test data was used to substantial equivalence. Non-clinical testing consisted of performance fatigue testing in accordance with the FDA Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments and ISO 14801 Dentistry Inplants Dynamic Farigue Test for Endosseous Dental Implants."
• Clinical Testing: "Non-Clinical test data was used of substantial equivalence."

This indicates that no clinical studies for AI performance were conducted or reported in this 510(k) summary. The "acceptance criteria" and "device performance" mentioned in your request, as well as details about sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance, are typically associated with the evaluation of AI/ML-enabled medical devices assessing diagnostic or prognostic performance. This document pertains to a traditional physical dental implant system, not an AI-powered device.

Therefore, I cannot provide the requested information regarding acceptance criteria and AI study details because they are not present in the provided text. The document focuses on establishing substantial equivalence for a physical medical device based on material, design, and non-clinical fatigue testing.

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