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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 / May 2026 / K253191

510(k) cleared

DCMhotbond zircon

Dental Creativ Management GmbH · May 21, 2026 · K253191

FDA cleared the DCMhotbond zircon from Dental Creativ Management GmbH on May 21, 2026 under K253191, 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 Sep 26, 2025. The decision came 237 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 Dental Creativ Management GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253191?

K253191 is the FDA 510(k) for DCMhotbond zircon, submitted by Dental Creativ Management GmbH. FDA's decision date was May 21, 2026, under product code EIH (Powder, Porcelain).

Who makes the DCMhotbond zircon?

Dental Creativ Management GmbH, based in Mecklenburg-Vorpommerin, is the applicant of record for K253191.

How long did the K253191 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on May 21, 2026, 237 days later.

← All decisions in May 2026