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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 / K252073

510(k) cleared

VOCO Profluorid Varnish + BioMin

Voco GmbH · May 1, 2026 · K252073

FDA cleared the VOCO Profluorid Varnish + BioMin from Voco GmbH on May 1, 2026 under K252073, a traditional 510(k). The device falls under product code LBH, Varnish, Cavity, regulated at 21 CFR 872.3260 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jul 2, 2025. The decision came 303 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Voco GmbH has 2 other decisions in the tracker over the last 12 months: K261357 (Grandio disc multicolor), K252606 (Bifix Veneer LC, Bifix Veneer Try-In).

Questions & Answers

What did FDA clear under K252073?

K252073 is the FDA 510(k) for VOCO Profluorid Varnish + BioMin, submitted by Voco GmbH. FDA's decision date was May 1, 2026, under product code LBH (Varnish, Cavity).

Who makes the VOCO Profluorid Varnish + BioMin?

Voco GmbH, based in Cuxhaven, is the applicant of record for K252073.

How long did the K252073 review take?

FDA received the submission on Jul 2, 2025 and issued its decision on May 1, 2026, 303 days later.

← All decisions in May 2026

Sources