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Spectra-System Dental Implants 2008 are comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. The implants are intended for use in the mandible and maxilla, in support of single unit or multiple unit cement or screw-receiving restorations and for the retention and support of overdentures. The implants are intended for immediate placement and function for the support of singletooth or multiple-tooth restorations, recognizing bone stability and appropriate occusal load requirements.

The Spectra-System Dental Implants 2008 system consists of implants, abutments, healing components, and screws for use in one or two-stage placement and restorations.

The provided text is a 510(k) summary for the Spectra-System Dental Implants 2008. This document outlines the device description, intended use, and comparison to predicate devices for regulatory approval. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information. The text is a regulatory submission for a dental implant, focusing on demonstrating substantial equivalence to previously approved devices, rather than presenting a detailed study of its performance against specific acceptance criteria.

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