FDA cleared the Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) from Guilin Kevin Peter Technology Co., Ltd. on Aug 31, 2026 under K261695, a traditional 510(k). The device falls under product code EBF, Material, Tooth Shade, Resin, regulated at 21 CFR 872.3690 as a Class 2 device. The review panel was Dental.
FDA logged the submission as received on May 22, 2026. The decision came 101 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Guilin Kevin Peter Technology Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K261514 (Calcium Hydroxide Temporary Filling Material (KP-Cal)), K261415 (Injectable Root Canal Sealer (KP-Root SP)).