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The GSIII System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The GSIII System is for single and two stage surgical procedures. It is not for immediate load.

The GS III System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. The GS III System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

I am sorry but this document does not contain the information you are looking for. The document is a 510(k) summary for a dental implant system (GS III System) and discusses its substantial equivalence to predicate devices, safety tests, and indications for use. It does not include details on acceptance criteria or a study proving the device meets specific performance metrics in the way you've outlined with performance data, sample sizes, expert ground truth, or comparative effectiveness studies.

The document primarily focuses on regulatory submission requirements for substantial equivalence, not a detailed clinical or performance study with the requested metrics.

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