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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 / March 2026 / K260783

510(k) cleared

Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One

Kulzer, LLC · Mar 11, 2026 · K260783

FDA cleared the Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One from Kulzer, LLC on Mar 11, 2026 under K260783, 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 Mar 10, 2026. The decision came 1 days later, inside the 90 FDA-day goal for a 510(k).

Kulzer, LLC has 2 other decisions in the tracker over the last 12 months: K254063 (iCEM Universal Plus), K243910 (Retraxil).

Questions & Answers

What did FDA clear under K260783?

K260783 is the FDA 510(k) for Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One, submitted by Kulzer, LLC. FDA's decision date was Mar 11, 2026, under product code EBF (Material, Tooth Shade, Resin).

Who makes the Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One?

Kulzer, LLC, based in South Bend, IN, is the applicant of record for K260783.

How long did the K260783 review take?

FDA received the submission on Mar 10, 2026 and issued its decision on Mar 11, 2026, 1 days later.

← All decisions in March 2026

Sources