(47 days)
The Flipo Curing Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.
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I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, expert qualifications, or adjudication methods. The document is a 510(k) clearance letter from the FDA for a dental curing light, confirming its substantial equivalence to a predicate device for its indicated use. It does not include any performance study data or a description of such studies.
§ 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.