
Belport Company, Inc., Gingi-Pak
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RODIN Titan 3D Resin is an FDA 510(k)-cleared medical device (K240688) manufactured by Belport Company, Inc., Gingi-Pak. 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 19, 2024. Regulation: 8.