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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 / April 2026 / K261261

510(k) cleared

Dura-Arch

Hangzhou SHINING3D Dental Technology Co., Ltd. · Apr 17, 2026 · K261261

FDA cleared the Dura-Arch from Hangzhou SHINING3D Dental Technology Co., Ltd. on Apr 17, 2026 under K261261, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code EBG, Crown And Bridge, Temporary, Resin, regulated at 21 CFR 872.3770 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Apr 16, 2026. The decision came 1 days later, inside the 90 FDA-day goal for a 510(k).

Hangzhou SHINING3D Dental Technology Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K261356 (Dura-Crown), K260170 (LumiCera), K253053 (Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)).

Questions & Answers

What did FDA clear under K261261?

K261261 is the FDA 510(k) for Dura-Arch, submitted by Hangzhou SHINING3D Dental Technology Co., Ltd.. FDA's decision date was Apr 17, 2026, under product code EBG (Crown And Bridge, Temporary, Resin).

Who makes the Dura-Arch?

Hangzhou SHINING3D Dental Technology Co., Ltd., based in Hangzhou, is the applicant of record for K261261.

How long did the K261261 review take?

FDA received the submission on Apr 16, 2026 and issued its decision on Apr 17, 2026, 1 days later.

← All decisions in April 2026

Sources