3M UNITEK LAVA CHAIRSIDE ORAL SCANNER

3M UNITEK LAVA CHAIRSIDE ORAL SCANNER is an FDA 510(k)-cleared medical device (K081961) manufactured by Brontes Technologies. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 4, 2008. Regulation: 8.