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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 / June 2026 / K261415

510(k) cleared

Injectable Root Canal Sealer (KP-Root SP)

Guilin Kevin Peter Technology Co., Ltd. · Jun 29, 2026 · K261415

FDA cleared the Injectable Root Canal Sealer (KP-Root SP) from Guilin Kevin Peter Technology Co., Ltd. on Jun 29, 2026 under K261415, 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 Apr 30, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Guilin Kevin Peter Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261415?

K261415 is the FDA 510(k) for Injectable Root Canal Sealer (KP-Root SP), submitted by Guilin Kevin Peter Technology Co., Ltd.. FDA's decision date was Jun 29, 2026, under product code KIF (Resin, Root Canal Filling).

Who makes the Injectable Root Canal Sealer (KP-Root SP)?

Guilin Kevin Peter Technology Co., Ltd., based in Guilin, is the applicant of record for K261415.

How long did the K261415 review take?

FDA received the submission on Apr 30, 2026 and issued its decision on Jun 29, 2026, 60 days later.

← All decisions in June 2026