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The 3.0 mm Bicon implants are designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework, support of the res, or as a single tooth replacement. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage implantationoroach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. The 3.0 Bicon implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors.

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The provided document is a 510(k) premarket notification letter from the FDA regarding a dental implant (3.0 x 8.0mm and 3.0 x 11mm Bicon Implant). It focuses on regulatory approval based on substantial equivalence to predicate devices.

This document does NOT contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a medical device AI/software.

The request asks for specific details about a study proving a device meets acceptance criteria, but these details are not present in the provided FDA letter. The letter is a regulatory approval notice, not a study report.

Therefore, I cannot fulfill the request using the provided text.

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