(31 days)
The SmartLite™ PS Pen-Style LED Curing Light is indicated for curing camphorquinone-based visible light cured (VLC) dental materials.
The SmartLite™ PS Pen-Style LED Curing Light is a cordless, battery-powered unit designed for curing VLC materials whose initiator systems are sensitive to light in the 450-475 nm wavelength region of the visible spectrum. The unit is based ion LED (light emitting diode) technology for light generation. The SmartLite™ PS Pen-Style LED Curing Light includes: A handpiece with control electronics and an inductively-recharged battery. A probe with a single LED at the tip. A base/recharger unit that plugs directly into main power. An optional eye shield.
This 510(k) summary describes a dental curing light, a medical device that does not rely on AI/ML. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and training data for AI/ML performance is not applicable to this document.
The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, operation, and technological characteristics (wavelength range, light source). It does not contain information related to AI/ML software performance or clinical studies in the context of AI/ML.
§ 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.