Somnos Anti-Snoring Mouth Guard

Somnos Anti-Snoring Mouth Guard is an FDA 510(k)-cleared medical device (K201484) manufactured by Koncept Innovators, LLC. 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 22, 2020. Regulation: 8.