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Carbon Fiber Bridge, Model 28757

FDA 510(k)

Class II (US FDA 510(k))

510(k) K031070

by Nobel Biocare AB

Identifiers

510(k) Number
K031070 FDA 510(k)
FDA Product Code
EBI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3760 FDA 510(k)
Regulation Number
872.3760 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Carbon Fiber Bridge, Model 28757 is a dental prosthetic framework designed as an alternative to gold or metal frameworks for denture bases. It consists of a carbon fiber tube, a two-part polymer resin, and titanium retention wires. The device is classified under product code EBI as a resin, denture, relining, repairing, and rebasing material.

The device is used in a laboratory setting where the carbon fiber tube is placed over perforating tips on a patient jaw model. The fibers are spread, titanium retention wires are inserted, and the framework is heat-polymerized before trimming and painting. It is supplied as a kit and is intended for single use. The device is regulated under FDA 510(k) clearance K031070 and is stored in a dry environment.

Frequently asked questions

What is the Carbon Fiber Bridge, Model 28757 used for?

It is a dental prosthetic framework designed as an alternative to gold or metal frameworks for denture bases. It is used in a laboratory setting where the carbon fiber tube is placed over perforating tips on a patient jaw model, spread, and combined with titanium retention wires before heat-polymerization.

How is the Carbon Fiber Bridge, Model 28757 supplied?

The device is supplied as a kit. It is intended for single use and is designed to be processed in a dental laboratory environment.

Is the Carbon Fiber Bridge, Model 28757 sterile?

The device data does not specify whether the Carbon Fiber Bridge, Model 28757 is supplied sterile. It is described as a kit intended for single use, but sterility is not mentioned as a feature or requirement.

What are the main components of the Carbon Fiber Bridge, Model 28757?

The framework consists of a carbon fiber tube, a two-part polymer resin, and titanium retention wires. These components are assembled and heat-polymerized during the fabrication process.

How should the Carbon Fiber Bridge, Model 28757 be stored?

The device should be stored in a dry environment. This is specified to maintain the integrity of the materials until use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K031070 FDA 510(k) - CARBON FIBER BRIDGE | Nobel Biocare AB, CARBON FIBER BRIDGE, MODEL 28757 (K031070) — FDA 510 (k) | Innolitics, PDF K031070 - Carbon Fiber Bridge, Model 28757

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nobel Biocare AB

Sources (1)

  • FDA 510(k) K031070 24 fields · synced Oct 6, 2026