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The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the prosthesis for the patient.

Endosseous implant system consists of implants, tools and abutments. This submission includes pre-machined angulated abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.

I'm sorry, but this document does not contain the information requested to describe the acceptance criteria and study proving device performance for a medical device. The document is a 510(k) summary for a dental implant system, primarily focusing on its substantial equivalence to predicate devices. It lists predicate devices, describes the device, and states its intended use, but it does not provide details on specific acceptance criteria for a study demonstrating performance, nor does it detail a study with performance metrics, sample sizes, ground truth establishment, or expert involvement as requested.

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