(37 days)
Activator for light-induced intraoral polymerization of resin dental pit and fissure sealant, restorative materials, bonding , or luting materials.
Translux Energy Light Curing Unit which is classified as an Ultraviolet Activator for Polymerization (21C.F.R. § 872.607). Translux® Energy has the same intended use and is substantially equivalent to Kulzer's already 510(K)-cleared light-curing unit Translux® EC [K892456]. The Translux ® Energy is a further development of the Translux® EC light source to provide the patient and user with more comfortable handling and more favorable properties.
The provided document is a 510(k) summary for the Heraeus Kulzer, Inc. Translux® Energy light-curing unit. It describes the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement that would be required to answer the requested questions. This document is a regulatory submission, not a scientific study report.
Therefore, I cannot extract the information required for the table and points 2-9 from 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.