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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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