DB-EZ Bone Void Filler

DB-EZ Bone Void Filler is an FDA 510(k)-cleared medical device (K212353) manufactured by Dimensional Bioceramics, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 21, 2021. Regulation: 8.