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The Nobelpharma CeraOne Abutment System is intended to be used to anchor single tooth prostheses in partially edentulous patients.

The Nobelpharma CeraOne Abutment System is an abutment used with an endosseous implant which is implanted in the upper or lower jaw bone. The CeraOne System allows the prosthesis to be cemented directly to the abutment rather than requiring an additional screw connection. The modifications to the device are the broadening and narrowing of the base and external diameters of the abutments; and broadening and narrowing of the diameters of the abutment screws, adding two series of abutments fitting to larger and smaller diameters of fixtures previously cleared.

This document is a 510(k) summary for a pre-market notification of a dental implant abutment system. It describes modifications to an existing device, primarily dimensional changes. It does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria related to a diagnostic or AI-driven medical device.

Therefore, I cannot provide the requested table or information regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details as this document is not about a performance-measuring study for such a device.

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