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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 / K260067

510(k) cleared

Eternal Art Porcelain Powders

Shandong Huge Dental Material Corporation · Apr 9, 2026 · K260067

FDA cleared the Eternal Art Porcelain Powders from Shandong Huge Dental Material Corporation on Apr 9, 2026 under K260067, 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 Jan 9, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Shandong Huge Dental Material Corporation has one other decision in the tracker over the last 12 months: K260376 (Denture Base).

Questions & Answers

What did FDA clear under K260067?

K260067 is the FDA 510(k) for Eternal Art Porcelain Powders, submitted by Shandong Huge Dental Material Corporation. FDA's decision date was Apr 9, 2026, under product code EIH (Powder, Porcelain).

Who makes the Eternal Art Porcelain Powders?

Shandong Huge Dental Material Corporation, based in Rizhao City, is the applicant of record for K260067.

How long did the K260067 review take?

FDA received the submission on Jan 9, 2026 and issued its decision on Apr 9, 2026, 90 days later.

← All decisions in April 2026

Sources