
Dentalez Group
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SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE is an FDA 510(k)-cleared medical device (K030133) manufactured by Dentalez Group. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 28, 2003. Regulation: 8.