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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 / K251465

510(k) cleared

Root canal repair materials (nRoot BP)

Enpuno Biotechnology Co., Ltd. · Sep 25, 2025 · K251465

FDA cleared the Root canal repair materials (nRoot BP) from Enpuno Biotechnology Co., Ltd. on Sep 25, 2025 under K251465, 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 May 13, 2025. The decision came 135 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 Enpuno Biotechnology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251465?

K251465 is the FDA 510(k) for Root canal repair materials (nRoot BP), submitted by Enpuno Biotechnology Co., Ltd.. FDA's decision date was Sep 25, 2025, under product code KIF (Resin, Root Canal Filling).

Who makes the Root canal repair materials (nRoot BP)?

Enpuno Biotechnology Co., Ltd., based in Changsha High-Tech Development Zone Chan, is the applicant of record for K251465.

How long did the K251465 review take?

FDA received the submission on May 13, 2025 and issued its decision on Sep 25, 2025, 135 days later.

← All decisions in September 2025