FDA Statement Re: K192233 Trade/Device Name: LED Curing LightRegulation Number: 21 CFR 872.6070Regulation Name: Ultraviolet Activator for PolymerizationRegulatory Class: Class IIProduct Code: EBZDated: December 7, 2019Received: December 16, 2019
Explore MoreETERFANT Woodpecker Style Dental Wireless O-LED Curing Light Lamp 1Second Curing High Power Resin Cure Lamp. – Focused Light Beam: Allows deeper curing depth and higher curing efficiency. – Upgrade Light Intensity: Up to 2000 mW/cm² for curing 2mm resin in 1 second.
Explore MoreETERFANT Woodpecker Style Dental Wireless O-LED Curing Light Lamp 1Second Curing High Power Resin Cure Lamp. – Focused Light Beam: Allows deeper curing depth and higher curing efficiency. – Upgrade Light Intensity: Up to 2000 mW/cm² for curing 2mm resin in 1 second.
Explore MoreSolidification effect……20s，>3mm (3W) ，6s，3mm (10W). The unit is using the LED which has 430—485nm wavelength in the dental operation．. This product is used in fast solidification by lighting dental resin.
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