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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.

The provided text does not describe acceptance criteria for a device's performance, nor does it detail a study that proves the device meets such criteria.

Instead, the document is a 510(k) premarket notification letter from the FDA regarding the K3Pro® Konus New Abutments and Implants. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing new performance criteria or conducting studies to meet specific acceptance thresholds.

The document discusses:

• Indications for Use: What the device is intended for.
• Technological Characteristics: How the device is similar to predicate devices in terms of materials, design, and manufacturing.
• Non-Clinical Testing: A list of tests performed (e.g., sterilization validation, biocompatibility, fatigue testing) to show that the new device performs similarly and safely to the predicate devices. These are equivalence tests, not performance tests against specified acceptance criteria.

Therefore, I cannot provide the requested information as it is not present in the given text. The document explicitly states: "No animal testing or human clinical trials have been conducted." and focuses on "similarities between the predicate and proposed devices" and "non-clinical performance to the predicates listed" to support substantial equivalence.

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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 provided text is a 510(k) Clearance letter from the FDA for a dental implant system. It does not contain any information about a study that proves a device meets acceptance criteria, an AI/ML powered device, or any performance metrics. Therefore, I cannot generate the requested information based on the input.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance, rather than requiring performance data against specific acceptance criteria as would be needed for a novel device or AI/ML product.

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Ask a specific question about this device

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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