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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 / K253036

510(k) cleared

Light-curing Coloring Materials (ALCM)

Aidite (Qinhuangdao) Technology Co., Ltd. · Apr 6, 2026 · K253036

FDA cleared the Light-curing Coloring Materials (ALCM) from Aidite (Qinhuangdao) Technology Co., Ltd. on Apr 6, 2026 under K253036, 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 Sep 22, 2025. The decision came 196 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 Aidite (Qinhuangdao) Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253036?

K253036 is the FDA 510(k) for Light-curing Coloring Materials (ALCM), submitted by Aidite (Qinhuangdao) Technology Co., Ltd.. FDA's decision date was Apr 6, 2026, under product code EBF (Material, Tooth Shade, Resin).

Who makes the Light-curing Coloring Materials (ALCM)?

Aidite (Qinhuangdao) Technology Co., Ltd., based in Qinhuangdao, is the applicant of record for K253036.

How long did the K253036 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Apr 6, 2026, 196 days later.

← All decisions in April 2026