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Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The ITI Esthetic abutments are indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.

The ITI 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 surgical and prosthetic parts and instruments. The devices covered by this submission are abutments which are placed into the dental implant to provide support for a prosthetic reconstruction. The subject abutments are indicated for cemented restorations, particularly in esthetic areas of the mouth.

The ITI esthetic abutments are made from commercially pure Grade 4 titanium (ASTM F67) with a titanium alloy screw. The basal portion of the abutment has conical taper with an inset octagonal design. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutment is available in two diameters for use with ITI implants with shoulder diameters of 4.8 mm and 6.5 mm.

The provided text is a 510(k) summary for a medical device (ITI Esthetic Ease Abutments) and does not describe acceptance criteria, a study proving device performance, or any of the other requested information related to an AI/ML-based device performance study.

The document is a regulatory submission for a dental implant abutment, outlining its description, intended use, and substantial equivalence to previously cleared predicate devices based on material and design specifications. It is a standard medical device clearance document, not a study report or performance evaluation in the context of AI/ML or a clinical trial with acceptance criteria.

Therefore, I cannot extract the requested information from the provided text.

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