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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 / May 2026 / K260805

510(k) cleared

Dual Core

Vericom Co., Ltd. · May 11, 2026 · K260805

FDA cleared the Dual Core from Vericom Co., Ltd. on May 11, 2026 under K260805, 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 Mar 12, 2026. The decision came 60 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: K252285 (Well-Root PT).

Questions & Answers

What did FDA clear under K260805?

K260805 is the FDA 510(k) for Dual Core, submitted by Vericom Co., Ltd.. FDA's decision date was May 11, 2026, under product code EBF (Material, Tooth Shade, Resin).

Who makes the Dual Core?

Vericom Co., Ltd., based in Chuncheon-Si, is the applicant of record for K260805.

How long did the K260805 review take?

FDA received the submission on Mar 12, 2026 and issued its decision on May 11, 2026, 60 days later.

← All decisions in May 2026