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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 / K260918

510(k) cleared

Zolid Lunaris

Amann Girrbach AG · Jun 29, 2026 · K260918

FDA cleared the Zolid Lunaris from Amann Girrbach AG on Jun 29, 2026 under K260918, 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 19, 2026. The decision came 102 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 Amann Girrbach AG in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260918?

K260918 is the FDA 510(k) for Zolid Lunaris, submitted by Amann Girrbach AG. FDA's decision date was Jun 29, 2026, under product code EIH (Powder, Porcelain).

Who makes the Zolid Lunaris?

Amann Girrbach AG, based in Maeder, is the applicant of record for K260918.

How long did the K260918 review take?

FDA received the submission on Mar 19, 2026 and issued its decision on Jun 29, 2026, 102 days later.

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