Search Results

3i Dental Implant Systems are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.

Implant Innovation's dental implant systems are available in a wide range of diameters and lengths. 3i implants include screw-form (i.e., threaded) or cylinder; are manufactured from titanium; and are coated or non-coated. The OSSEOTITE® brand implants have a special dual acid-etched treatment process to increase surface roughness.

The provided text is a U.S. FDA 510(k) summary for a dental implant system. It outlines the device, its indications for use, and a comparison to predicate devices, ultimately leading to a substantial equivalence determination.

However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.

The document is a regulatory submission for premarket notification, not a clinical study report. It focuses on demonstrating substantial equivalence to existing devices, which is a different type of evaluation than proving a device meets specific performance criteria through a dedicated study.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Ask a specific question about this device

The "Dual Integrator" Healing Cap, Implant Carrier Assembly, and Activator Pin Driver are all intended to be used with the Implant Integration Systems "Dual Integrator" Dental Implant (K944225).

Not Found

The provided document is a "Summary of Safety and Effectiveness Information" for a dental implant accessory ("Dual Integrator" Healing Cap, Implant Carrier Assembly, and Activator Pin Driver) from Implant Integration Systems, Inc., dated October 18, 1996.

This document does not contain any information regarding acceptance criteria, device performance, clinical study design, sample sizes, expert involvement, or any of the other specific details requested in your prompt.

It is a regulatory submission describing the product and its similarity to other existing devices, rather than a report on clinical trial results or performance studies.

Therefore,Based on the provided document, I cannot fulfill your request as it does not contain the necessary information to describe the acceptance criteria and the study that proves the device meets them.

Ask a specific question about this device