(27 days)
The Jetlite 5000 is intended to polymerize (set) resinous dental pit and fissure sealants or dental restorative materials by transmission of light through a rod.
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This document is a 510(k) clearance letter from the FDA for a device called "Jetlite 5000", which is an Ultraviolet Activator for Polymerization. It acknowledges the substantial equivalence of the device to legally marketed predicate devices.
However, the provided text does not contain any information regarding acceptance criteria, device performance results, study details (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or multi-reader multi-case comparative effectiveness studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the given input. The document is merely a regulatory clearance and does not contain the technical study details you are asking for.
§ 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.