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NobelActive Multi Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

NobelActive Multi Unit Abulments are artificial tooth abutments designed to fit and function on the NobelActive Implants. It is an internal hexagonal design similar to the previous SFB (renamed NobelActive) Abutments. The material of construction is the same as the previous SFB Abutments. The NobelActive Multi Unit Abutments differ from the predicate device in trade name and design.

This document is a 510(k) summary for the NobelActive Multi Unit Abutment. It is a premarket notification for a medical device and therefore does not contain acceptance criteria for device performance in the context of a study, nor does it present the results of a study to demonstrate such performance or discuss any AI components.

The document focuses on:

• Legal Information: Submission details, classification names, trade names, and legally marketed predicate devices.
• Device Description: Material and design differences/similarities to predicate devices.
• Indications for Use: The intended purpose of the device (prosthetic rehabilitation).
• FDA Correspondence: Official letter from the FDA determining substantial equivalence to predicate devices, allowing the device to be marketed.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth, expert information, MRMC studies, or standalone algorithm performance) from the provided text. This type of information is typically found in clinical trial reports, validation studies, or performance testing summaries, which are not part of this 510(k) summary.

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