510(k) K232498

UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio by Ultradent Product, Inc. — Product Code EBC

K232498 is an FDA 510(k) premarket notification submitted by Ultradent Product, Inc. for the device "UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio". The FDA issued a decision of Substantially Equivalent on August 18, 2023. The device falls under product code EBC (Sealant, Pit And Fissure, And Conditioner), a Class II device regulated under 21 CFR 872.3765. Ultradent Product, Inc. has at least 1 other 510(k) clearance on record.