(63 days)
The Optilux Curing Lights are visible light curing units intended for polymerization of light cure materials.
The Optilux Curing Lights, Models 380, 401 and 405, are devices used for the polymerization of dental materials using visible light. They consist of a control unit and cord connected handpiece. The molded plastic control units house the printed circuit board with control circuitry for the lamp and cooling fan. Additionally, the printed circuit board for the Model 380 contains control circuitry for radiometer functions. Model 380 also has a permanently attached power cord, however the power cords on Models 401 and 405 are detachable. The handpiece cord attached to the Model 405 is separable by a panel mount connector, which allows the control unit to be installed inside a cabinet or dental chair.
The molded plastic handpieces contain a low voltage halogen lamp, optical filter assembly and a fiber optic light guide that generates visible (blue-white) light energy having a bandwidth of approximately 400 - 515 nm. The handpieces also contain a small printed circuit board with a micro-switch for activation of the curing lamp.
The provided text is a 510(k) summary for a medical device (Optilux Curing Lights) and an FDA clearance letter. It does not describe acceptance criteria for performance, a study proving the device meets those criteria, or any details related to AI/algorithm performance. It focuses on the device's description, intended use, and substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information as it is not present in the provided document.
To fulfill the request, a document detailing device performance studies and acceptance criteria for an AI/algorithm-based medical device would be needed.
§ 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.