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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 / June 2026 / K262195

510(k) cleared

Dandy Ceramic Stain and Glaze

Zima International Inc., dba Dandy · Jun 30, 2026 · K262195

FDA cleared the Dandy Ceramic Stain and Glaze from Zima International Inc., dba Dandy on Jun 30, 2026 under K262195, a traditional 510(k) reviewed through the Third Party Review Program. 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 Jun 29, 2026. The decision came 1 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Zima International Inc., dba Dandy in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262195?

K262195 is the FDA 510(k) for Dandy Ceramic Stain and Glaze, submitted by Zima International Inc., dba Dandy. FDA's decision date was Jun 30, 2026, under product code EIH (Powder, Porcelain).

Who makes the Dandy Ceramic Stain and Glaze?

Zima International Inc., dba Dandy, based in New York, NY, is the applicant of record for K262195.

How long did the K262195 review take?

FDA received the submission on Jun 29, 2026 and issued its decision on Jun 30, 2026, 1 days later.

← All decisions in June 2026