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The Bicon Two Part Abutment is designed for use in the mandible or maxilla for the support of a terminal or intermediate crown for fixed bridgework or for a single tooth crown.

Two Part Abutment System

This document is a 510(k) clearance letter from the FDA for a dental implant product (Bicon Dental Implants Two Part Abutment System). It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this type of FDA clearance letter does not contain the detailed information about acceptance criteria, specific device performance studies, sample sizes, ground truth establishment, or expert qualifications that you are requesting.

A 510(k) clearance primarily focuses on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics as a device already on the market, or if there are differences, those differences do not raise new questions of safety and effectiveness.

To find the information you are looking for (acceptance criteria, study details, etc.), you would typically need to refer to:

• The actual 510(k) submission document: This is a much more extensive document submitted by the manufacturer to the FDA, detailing all the testing and data. These are often not publicly available in their entirety, though summaries (like the FDA's "Summary of Safety and Effectiveness" or "510(k) Premarket Notification") might be.
• Published scientific literature: Manufacturers often publish studies related to their devices in peer-reviewed journals.
• Manufacturer's technical documentation: Information provided directly by Bicon, Incorporated for their device.

Therefore, based solely on the provided text, I cannot answer your specific questions. The text only states that the device is substantially equivalent to predicate devices for its intended use, which is for supporting crowns in the mandible or maxilla.

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