Acrylic Herbst Appliance with Micro-Recorder

Acrylic Herbst Appliance with Micro-Recorder is an FDA 510(k)-cleared medical device (K170606) manufactured by Gergen'S Orthodontic Lab. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 15, 2017. Regulation: 8.