510(k) K030133

SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE by Dentalez Group — Product Code EBF

K030133 is an FDA 510(k) premarket notification submitted by Dentalez Group for the device "SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE". The FDA issued a decision of Substantially Equivalent on April 29, 2003. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Dentalez Group has at least 10 other 510(k) clearances on record.