Search Results

The Ritter Implants are intended for simple or multiple replacements of lost teeth and provide a way to attach the prosthetic pieces in totally or partially edentulous patients.

Ritter Implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Not Found

This document is an FDA 510(k) clearance letter for a medical device, specifically dental implants called "Ritter Implants." It confirms that the FDA has reviewed the manufacturer's premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications. The document is a regulatory clearance letter, not a clinical study report or a summary of performance data.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them because that information is not present in the provided text.

Ask a specific question about this device