Search Results

The RMO Plasma Curing Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.

Not Found

This is an FDA 510(k) clearance letter for a dental device, specifically a "RMO Plasma Curing Light." This document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA has determined that the new device is as safe and effective as a device already on the market. This often involves comparing the new device's technological characteristics and performance data to that of the predicate device, but the details of such a comparison are not included in this document.

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

Ask a specific question about this device

The Flipo Curing Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, expert qualifications, or adjudication methods. The document is a 510(k) clearance letter from the FDA for a dental curing light, confirming its substantial equivalence to a predicate device for its indicated use. It does not include any performance study data or a description of such studies.

Ask a specific question about this device