
Ultradent Product, Inc.
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UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio is an FDA 510(k)-cleared medical device (K232498) manufactured by Ultradent Product, 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 August 17, 2023. Regulation: 8.