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The Bicon implant is designed for use in edentulous sites in the mandible or maxilla for support of a completed denture prosthesis, a terminal or intermediate abutment for fixed bridgework, partial dentures, or a single tooth replacement.

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The provided text is a 510(k) clearance letter from the FDA for the Biconite Surface Treatment, a component of the Bicon implant system. This document is a regulatory clearance and does not contain information about acceptance criteria or a study proving device performance against such criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on its substantial equivalence to an existing device, not through a study demonstrating its performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not present in this document.

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