FRIALIT-2 BONE PROFILER

FRIALIT-2 BONE PROFILER is an FDA 510(k)-cleared medical device (K993560) manufactured by Friadent GmbH. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 9, 2000. Regulation: 8.