
Prismatik Dentalcraft, Inc.
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Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG) is an FDA 510(k)-cleared medical device (K233434) manufactured by Prismatik Dentalcraft, 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 November 13, 2023. Regulation: 8.