
Frantz Design, Inc.
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ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE is an FDA 510(k)-cleared medical device (K971794) manufactured by Frantz Design, 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 September 28, 1997. Regulation: 8.