
Prismatik Dentalcraft, Inc.
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BruxZir® Shaded 16 PLUS is an FDA 510(k)-cleared medical device (K254283) 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 January 29, 2026. Regulation: 8.