TruGuard Custom Tongue and Jaw Positioner

TruGuard Custom Tongue and Jaw Positioner is an FDA 510(k)-cleared medical device (K153270) manufactured by Bionix Development Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 7, 2016. Regulation: 8.