(57 days)
For the polymerization of visible light cured dental materials.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a dental curing light, the Aurora™. This document mainly addresses the regulatory clearance process and substantial equivalence to a predicate device. It does not contain information regarding detailed acceptance criteria for a study, nor does it describe a study that proves the device meets specific performance criteria.
Therefore, I cannot provide the requested information from the given text.
In general, for a medical device cleared via the 510(k) pathway, the "acceptance criteria" and "study data" are typically found in the 510(k) submission itself, often in sections detailing performance testing and bench testing. The FDA clearance letter summarizes the regulatory decision but does not usually include the granular details of the performance study.
§ 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.