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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / September 2025 / K252285

510(k) cleared

Well-Root PT

Vericom Co., Ltd. · Sep 19, 2025 · K252285

FDA cleared the Well-Root PT from Vericom Co., Ltd. on Sep 19, 2025 under K252285, 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 Jul 23, 2025. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

Vericom Co., Ltd. has one other decision in the tracker over the last 12 months: K260805 (Dual Core).

Questions & Answers

What did FDA clear under K252285?

K252285 is the FDA 510(k) for Well-Root PT, submitted by Vericom Co., Ltd.. FDA's decision date was Sep 19, 2025, under product code KIF (Resin, Root Canal Filling).

Who makes the Well-Root PT?

Vericom Co., Ltd., based in Chuncheon-Si, is the applicant of record for K252285.

How long did the K252285 review take?

FDA received the submission on Jul 23, 2025 and issued its decision on Sep 19, 2025, 58 days later.

← All decisions in September 2025