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Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.

Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.

Temporary Copings are intended to serve as a base for temporary restorations for up to 28 days.

The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surqical and prosthetic parts and instruments.

Abutments are placed into dental implants to provide support for prosthetic restorations, temporary copings support a temporary restoration out of occlusion and protective caps protect the abutment during the healing phase.

This document, K072071, is a 510(k) premarket notification for dental abutments, temporary copings, and protective caps. It claims substantial equivalence to previously marketed devices. Crucially, this submission does not describe a study involving device performance against acceptance criteria in the context of an AI/software device or a comparative effectiveness study involving human readers.

The document details the regulatory classification, intended use, and substantial equivalence to predicate devices (physical dental components). It confirms that the new devices have the same material composition, basic design, and fundamental operating principles as the cleared predicate devices.

Therefore, I cannot extract the requested information such as acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or results of MRMC or standalone studies because this is not a study about an AI/software device.

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