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THE TAPE

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 / March 2026 / K252606

510(k) cleared

Bifix Veneer LC, Bifix Veneer Try-In

Voco GmbH · Mar 20, 2026 · K252606

FDA cleared the Bifix Veneer LC, Bifix Veneer Try-In from Voco GmbH on Mar 20, 2026 under K252606, a traditional 510(k). The device falls under product code EMA, Cement, Dental, regulated at 21 CFR 872.3275 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Aug 18, 2025. The decision came 214 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: K252073 (VOCO Profluorid Varnish + BioMin), K261357 (Grandio disc multicolor).

Questions & Answers

What did FDA clear under K252606?

K252606 is the FDA 510(k) for Bifix Veneer LC, Bifix Veneer Try-In, submitted by Voco GmbH. FDA's decision date was Mar 20, 2026, under product code EMA (Cement, Dental).

Who makes the Bifix Veneer LC, Bifix Veneer Try-In?

Voco GmbH, based in Cuxhaven, is the applicant of record for K252606.

How long did the K252606 review take?

FDA received the submission on Aug 18, 2025 and issued its decision on Mar 20, 2026, 214 days later.

← All decisions in March 2026

Sources