Search Results

Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The ITI synOcta Measo abutments are indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used in single tooth replacements and 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 the ITI synOcta Meso Abutments, a dental device. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a performance study with detailed acceptance criteria and testing results like those for AI/ML devices.

Therefore, none of the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment is present in the provided text.

The document states:

• Basis for Substantial Equivalence: "The ITI esthetic abutments are substantially equivalent in intended use, material, and design to the ITI esthetic ease abutments previously cleared under K020096."

This indicates that the submission relies on demonstrating similarity to an already cleared device, rather than presenting a de novo performance study against specific acceptance criteria.

Ask a specific question about this device