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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 / February 2026 / K251587

510(k) cleared

VITA VMLC Primer

Vita Zahnfabrik H. Rauter GmbH & Co. Kg. · Feb 23, 2026 · K251587

FDA cleared the VITA VMLC Primer from Vita Zahnfabrik H. Rauter GmbH & Co. Kg. on Feb 23, 2026 under K251587, a traditional 510(k). The device falls under product code KLE, Agent, Tooth Bonding, Resin, regulated at 21 CFR 872.3200 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on May 23, 2025. The decision came 276 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 Vita Zahnfabrik H. Rauter GmbH & Co. Kg. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251587?

K251587 is the FDA 510(k) for VITA VMLC Primer, submitted by Vita Zahnfabrik H. Rauter GmbH & Co. Kg.. FDA's decision date was Feb 23, 2026, under product code KLE (Agent, Tooth Bonding, Resin).

Who makes the VITA VMLC Primer?

Vita Zahnfabrik H. Rauter GmbH & Co. Kg., based in Baden-Wurttemberg, is the applicant of record for K251587.

How long did the K251587 review take?

FDA received the submission on May 23, 2025 and issued its decision on Feb 23, 2026, 276 days later.

← All decisions in February 2026