(164 days)
For light curing polymerization of light-curing dental materials curing in the wavelength range of 385-515 nm. These materials include restoratives, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting mateirals for brackets and indirect restorations, such as ceramic inlays.
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This document is a 510(k) clearance letter from the FDA for a dental curing light, the Bluephase® Style. It approves the device based on substantial equivalence to existing devices. However, this type of document does not contain the detailed study information, acceptance criteria, or performance data that you are requesting.
The FDA 510(k) clearance process primarily assesses whether a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or if it has different technological characteristics, that it does not raise different questions of safety and effectiveness and that the data demonstrate that the device is at least as safe and effective as the legally marketed device. This often relies on a comparison to predicate devices rather than requiring extensive new clinical trials with detailed performance metrics and statistical analyses as would be found in a PMA (Premarket Approval) application.
Therefore, I cannot extract the information you requested from this document. The document only confirms the device's clearance and its intended use.
§ 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.