TKO Composite Bite Turbo Gel

TKO Composite Bite Turbo Gel is an FDA 510(k)-cleared medical device (K210349) manufactured by Reliance Orthodontic Products, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 19, 2021. Regulation: 8.