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The BioHorizons Dental Implant System may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.

The BioHorizons Dental Implant System is a comprehensive system containing implants, surgical components, and prosthetic components. The implants are specifically designed to optimize strain distribution to contiguous bone under functional loading in order to promote strain-induced bone growth and interface maintenance over the long term. This improvement in biomechanical performance is achieved by optimizing implant designs specifically for each bone density classification (D1, D2, D3, D4) in the mandible and maxilla. Four implant designs, corresponding to each bone density classification, are available in four and five mm diameters. Each implant design, manufactured from titanium alloy conforming to ASTM F 136, is available in two lengths and may feature a titanium plasma-spray (TPS) or hydroxyapatite (HA) coating.

This document is a 510(k) summary for a dental implant system. It describes the device and its intended use, but it does not contain information on acceptance criteria for a study demonstrating device performance based on clinical outcomes or a comparison to an AI model.

The "Product Evaluation" section states that evaluation consisted of "mechanical testing of the implant and bioactive coating mechanical tests." This indicates an engineering or lab-based evaluation, not a clinical study involving human patients or an AI algorithm.

Therefore, I cannot provide the requested table or study details as they are not present in the provided text.

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The BioHorizons Dental Implant System may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.

The BioHorizons Dental Implant System is a comprehensive system containing implants. surgical components, and prosthetic components. The implants are specifically designed to optimize strain distribution to contiguous bone under functional loading in order to promote strain-induced bone growth and interface maintenance over the long term. This improvement in biomechanical performance is achieved by optimizing implant designs specifically for each bone density classification (D1, D2, D3, D4) in the mandible and maxilla.

Four implant designs, corresponding to each bone density classification, are available in four and five mm diameters. Each implant design, manufactured from titanium alloy conforming to ASTM F 136, is available in two lengths and may feature a glass bead, titanium plasma-spray (TPS), or hydroxyapatite (HA) coating.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets it. The text describes a dental implant system, its components, classification, and manufacturing details. It also mentions product evaluation methods but does not provide specific acceptance criteria or study results related to their achievement.

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