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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 / July 2026 / K261046

510(k) cleared

Dental Zirconia Blank & Coloring Liquid

Hunan Qinghao Puzhong Technology Co., Ltd. · Jul 17, 2026 · K261046

FDA cleared the Dental Zirconia Blank & Coloring Liquid from Hunan Qinghao Puzhong Technology Co., Ltd. on Jul 17, 2026 under K261046, a traditional 510(k). The device falls under product code EIH, Powder, Porcelain, regulated at 21 CFR 872.6660 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Mar 31, 2026. The decision came 108 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 Hunan Qinghao Puzhong Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261046?

K261046 is the FDA 510(k) for Dental Zirconia Blank & Coloring Liquid, submitted by Hunan Qinghao Puzhong Technology Co., Ltd.. FDA's decision date was Jul 17, 2026, under product code EIH (Powder, Porcelain).

Who makes the Dental Zirconia Blank & Coloring Liquid?

Hunan Qinghao Puzhong Technology Co., Ltd., based in Zhuzhou, is the applicant of record for K261046.

How long did the K261046 review take?

FDA received the submission on Mar 31, 2026 and issued its decision on Jul 17, 2026, 108 days later.

← All decisions in July 2026