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The Dentis Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures and not for immediate load. Also, this system is intended to be used in the molar region.

The Dentis Dental Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper and / or lower jaw arches. This 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.

The provided text is a 510(k) summary for the Dentis Dental Implant System. It outlines the device information, indications for use, and a comparison to predicate devices, ultimately stating substantial equivalence. However, it does not include any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, it is not possible to complete the requested table and study description based on the provided input.

The 510(k) summary focuses on demonstrating equivalence to previously cleared devices rather than providing detailed performance study data against specific acceptance criteria. This is typical for 510(k) submissions where clinical performance is often inferred from the predicate device through non-clinical testing (e.g., material properties, mechanical testing) and comparison of intended use.

To answer your questions, additional documentation beyond this 510(k) summary would be required, such as a detailed test report or clinical study report.

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