
American Sleep Association
Free shipping on orders over $99 · 30-day returns
ASA ORAL APPLIANCES is an FDA 510(k)-cleared medical device (K130504) manufactured by American Sleep Association. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 17, 2013. Regulation: 8.