(26 days)
Activator for light-induced intraoral polymerization of resin dental pit and fissure sealant, restorative materials, bonding , or luting materials.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a dental curing light, the Translux® Power Blue. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria or the study that proves the device meets specific performance criteria.
The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices. While manufacturers typically conduct internal testing to ensure their devices meet performance and safety standards, the FDA 510(k) summary (which is generally a separate document from the clearance letter itself) would contain details about such studies and acceptance criteria if they are deemed necessary for demonstrating substantial equivalence.
Therefore, I cannot provide the requested information based on the text you've provided. The document focuses on regulatory clearance, not detailed performance studies or specific acceptance criteria for the device itself.
§ 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.