(71 days)
The Luma Light 2000 Cure Light is a high intensity filtered light source, and optical delivery system, that produces curing of photo-activated dental or photo-activated bleaching formulations at four (4) times the rate of conventional light systems. The Luma Light 2000 Cure Light cures all photo activated dental materials such as those used in direct restorations, sealants, bonding agents and primers.
The Luma Light 2000 Cure Light is a high intensity filtered light source, and optical delivery system, that produces curing of photo-activated dental or photo-activated bleaching formulations at four (4) times the rate of conventional light systems.
This 510(k) summary (K992102) is for the Luma Light 2000 Cure Light. However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets them. This document is a premarket notification for substantial equivalence, comparing the Luma Light 2000 Cure Light to predicate devices. It states that the intended use and technical specifications are "virtually identical" to the predicate devices and that the differences "only make it easier to use, more reliable and more adaptable."
Therefore, I cannot provide the requested information from this document. The sections you asked for, such as acceptance criteria table, sample sizes, expert qualifications, etc., are typical for clinical performance studies, which are not detailed in this 510(k) submission.
This document focuses on regulatory approval based on substantial equivalence, not on providing a study report with performance metrics against pre-defined acceptance criteria.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.