INTRAORAL MANDIBULAR DISTRACTION DEVICE

INTRAORAL MANDIBULAR DISTRACTION DEVICE is an FDA 510(k)-cleared medical device (K970256) manufactured by Medicon EG. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 10, 1997. Regulation: 8.