SleepTight Mouthpiece STZ

SleepTight Mouthpiece STZ is an FDA 510(k)-cleared medical device (K191618) manufactured by Michael D Williams Dds PA. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 10, 2019. Regulation: 8.