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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 / March 2026 / K260370

510(k) cleared

Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Bloomden Bioceramics (HuNan) Co., Ltd. · Mar 30, 2026 · K260370

FDA cleared the Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank from Bloomden Bioceramics (HuNan) Co., Ltd. on Mar 30, 2026 under K260370, 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 Feb 5, 2026. The decision came 53 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Bloomden Bioceramics (HuNan) Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260370?

K260370 is the FDA 510(k) for Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, submitted by Bloomden Bioceramics (HuNan) Co., Ltd.. FDA's decision date was Mar 30, 2026, under product code EIH (Powder, Porcelain).

Who makes the Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

Bloomden Bioceramics (HuNan) Co., Ltd., based in Changsha, is the applicant of record for K260370.

How long did the K260370 review take?

FDA received the submission on Feb 5, 2026 and issued its decision on Mar 30, 2026, 53 days later.

← All decisions in March 2026