
Specialty Appliance Works, Inc.
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ACRYLIC HERBST SPLINT APPLIANCE is an FDA 510(k)-cleared medical device (K083209) manufactured by Specialty Appliance Works, 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 January 26, 2009. Regulation: 8.