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The Carbon Fiber Bridge is indicated for use as a denture base material providing reinforcement of prosthetic reconstructions in the treatment of fully or partially edentulous patients in order to restore the patient's chewing function.

The Carbon Fiber Bridge provides an alternative to traditional gold/metal framework in the creation of denture bases. The Carbon Fiber Bridge is sold in the form of a kit and uses carbon fibers infused with a 2-part polymer, which when hardened together becomes the denture frame. The kit contains a carbon fiber tube, the 2-part polymer resin, titanium retention gloves and mask, and instructions for use.

The shape of the carbon fiber bridge is formed using a model of the patient's jaw. Laboratory cylinders and perforating tips are placed in the model. Using a mounting tool, the carbon fiber tube is placed over the perforating tips, piercing the tube and spreading the carbon fibers. Titanium retention wires are then placed in proposed teeth locations, and the framework is polymenzed by heat. After polymenzation, the carbon fiber tube and retention wires are trimmed. The carbon fiber frame is then painted, using standard laboratory materials, to a preferred color as desired by the laboratory and the prosthetic teeth are attached with common dental acrylic materials wrapped around the framework.

The finished prosthetic reconstruction is then ready to be placed in the patient's jaw using existing techniques in the placement of endosseous implants and dentures.

This document is a 510(k) summary for the Carbon Fiber Bridge, a denture base material. It primarily focuses on the device's description, indications for use, and its substantial equivalence to previously marketed devices. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot provide the requested information from the given text. The document acts as a regulatory submission for market clearance based on equivalence, not a detailed technical report on performance testing.

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