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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 eacilitate the prosthetic phase and installation of the prosthesis for the patient.

Endosseous implant system consists of implants, tools and This submission includes pre-machined angulated abutments. 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.

The provided text describes a 510(k) summary for an endosseous implant system, focusing on its substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study demonstrating the device meets such criteria. The document is primarily a letter to the FDA seeking approval, outlining the device's description, intended use, and technological characteristics by comparing them to existing cleared devices.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets them based only on the provided text. The document is a regulatory submission, not a study report.

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