
Somnomed, Inc.
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SOMNODENT HERBST; CLASSIC, FLEX is an FDA 510(k)-cleared medical device (K130558) manufactured by Somnomed, 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 May 16, 2013. Regulation: 8.