Fiber Disks and Blocks (TRINIA)

Fiber Disks and Blocks (TRINIA) is an FDA 510(k)-cleared medical device (K143524) manufactured by Bicon, LLC. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 1, 2015. Regulation: 8.