Search Results

The Flexi-Lume LED System is intended to polymerize dental materials, restorative composite materials, orthodontic brackets bonding and sealing materials, restorative composite materials, enneded of visible light. It is matenals that are process poympatient's oral structures. It is also intended for bleaching arocedures to apply light to a tooth after it is treated with a bleaching agent.

The Flexi-Lume LED System is classified as an Ultraviolet Activator for Polymerization (21 CFR 872.6070) because it is a device intended for the photo-polymerization of light-cured dental materials. The Flexi-Lume contains a multifunction LED that directs light via a fiber optic gooseneck to the patient's mouth. The LED light has several modes: Daylight white (color temperature 5500K), Fluorescent white (color temperature 3500K), Transdental Illumination, Bleaching Light, Non-Curing light (all visible wavelengths excluding blue wavelengths), and Curing Light. The Curing Light mode produces visible blue light in the 430-490nm waveband of the light spectrum with a power density of 1,500mW/cm2. This power density is sufficient for the product intended uses, generally the photo-polymerization of visible light cured dental materials, restorative composite materials, orthodontic brackets and orthodontic bonding and sealing materials. The different lighting modes can be selected with touch controls on the housing. The touch controls also include a dimmer which allows the selection of light intensity in all modes except Curing and Bleaching, which have pre-set intensity levels. The Flexi-Lume runs on 12VDC, powered by a certified AC/DC adapter that can be hidden inside the dental chair.