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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 / K261357

510(k) cleared

Grandio disc multicolor

Voco GmbH · Apr 27, 2026 · K261357

FDA cleared the Grandio disc multicolor from Voco GmbH on Apr 27, 2026 under K261357, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code EBF, Material, Tooth Shade, Resin, regulated at 21 CFR 872.3690 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Apr 24, 2026. The decision came 3 days later, inside the 90 FDA-day goal for a 510(k).

Voco GmbH has 2 other decisions in the tracker over the last 12 months: K252073 (VOCO Profluorid Varnish + BioMin), K252606 (Bifix Veneer LC, Bifix Veneer Try-In).

Questions & Answers

What did FDA clear under K261357?

K261357 is the FDA 510(k) for Grandio disc multicolor, submitted by Voco GmbH. FDA's decision date was Apr 27, 2026, under product code EBF (Material, Tooth Shade, Resin).

Who makes the Grandio disc multicolor?

Voco GmbH, based in Cuxhaven, is the applicant of record for K261357.

How long did the K261357 review take?

FDA received the submission on Apr 24, 2026 and issued its decision on Apr 27, 2026, 3 days later.

← All decisions in April 2026

Sources