(69 days)
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.
§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.