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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 / K253053

510(k) cleared

Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)

Hangzhou SHINING3D Dental Technology Co., Ltd. · Sep 23, 2025 · K253053

FDA cleared the Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) from Hangzhou SHINING3D Dental Technology Co., Ltd. on Sep 23, 2025 under K253053, a traditional 510(k) reviewed through the Third Party Review Program. 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 Sep 22, 2025. 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), K261261 (Dura-Arch), K260170 (LumiCera).

Questions & Answers

What did FDA clear under K253053?

K253053 is the FDA 510(k) for Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1), submitted by Hangzhou SHINING3D Dental Technology Co., Ltd.. FDA's decision date was Sep 23, 2025, under product code EBF (Material, Tooth Shade, Resin).

Who makes the Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)?

Hangzhou SHINING3D Dental Technology Co., Ltd., based in Hangzhou, is the applicant of record for K253053.

How long did the K253053 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Sep 23, 2025, 1 days later.

← All decisions in September 2025

Sources