FDA cleared the NeoPEX Pre-Mixed Obturation Paste from NuSmile, Ltd. on Sep 4, 2026 under K253909, a traditional 510(k). The device falls under product code KIF, Resin, Root Canal Filling, regulated at 21 CFR 872.3820 as a Class 2 device. The review panel was Dental.
FDA logged the submission as received on Dec 8, 2025. The decision came 270 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
This is the only decision on file for NuSmile, Ltd. in the last 12 months of the tracker.