(38 days)
The L.E.Demetron II is an L.E.D. visible light curing unit intended for polymerization of light cure materials by dental professionals.
The L.E.Demetron II cordless curing light is a device used for the polymerization of dental materials using visible light. It consists of a cordless LED curing handpiece, a battery pack, a battery charger with built-in radiometer and a remote handpiece holder. The plastic molded handpiece contains an LED light source, a cooling fan and a digital electronic circuit consisting of surface mount components mounted on circuit boards. The handpiece functions, LED online cooling fan, display output, curing mode selection and low battery indicators, are controlled by the digital electronic circuit and a Complex Programmable Logic Device (CPLD) chiponionous of C into the control circuitry. The handpiece has a mode select button for activating the hondpoiece and selecting the desired curing mode. A second "trigger" button is used to activate the LED output. The handpiece is powered by a removable 4 cell, low voltage, Ni-MH battery pack. 22 volded plastic, triangular enclosure houses a printed circuit board with control circuitry for the battery charging function and the LED curing radiometer.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for the L.E.Demetron II, a dental curing light, which focuses on establishing substantial equivalence to a predicate device rather than detailing performance studies against specific acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies. The document only describes the device, its intended use, and claims substantial equivalence to another marketed device.
§ 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.