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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 prospectives consideration for for the patient.

Endosseous implant system consists of implants, tools and abutments long the 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 prostheric attachments are fabricated to these abutments.

This document is a 510(k) summary for dental implant abutments. It does not contain information about acceptance criteria or a study proving that a device meets such criteria because it describes a device that is substantially equivalent to predicate devices already on the market, rather than a novel device requiring new performance studies.

Therefore, I cannot provide the requested information.

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