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Implant systems are for use in single tooth, partially edentulous, completely edentulous, mandibles and maxillae as a support or attachment for prosthetic restoration. The restoration can be detachable (screw relained) prosthetics in multiple, free standing or terminal restorations.

The conical abutment is designed for use with an endosseous implant which is implanted in the lower or upper jaw. The conical abutment provides a base for the restorative crown or bridgework.

The provided text is a 510(k) Summary for a medical device called "Lifecore Conical Abutment." This document focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and study results for device performance in the way a clinical study report would.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document, as it is not present. The summary states:

• "The technological characteristics of the modified version of the conical abutment and the earlier versions are identical. The titanium used in both devices is the same. Manufacturing processes are also the same as is general shape and structure. Therefore, no new types of technology and no new technological questions are involved."

This statement indicates that the submission is based on the premise that the new device is essentially the same as a previously cleared version, and thus does not require new performance studies with specific acceptance criteria that would typically be detailed in a clinical trial report.

To provide the requested information, a document describing a de novo approval process or a clinical study for a novel device would be necessary.

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