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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 / July 2026 / K261485

510(k) cleared

Tetric plus Fill;Tetric plus Flow

Ivoclar Vivadent, Inc. · Jul 1, 2026 · K261485

FDA cleared the Tetric plus Fill;Tetric plus Flow from Ivoclar Vivadent, Inc. on Jul 1, 2026 under K261485, a traditional 510(k). 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 May 5, 2026. The decision came 57 days later, inside the 90 FDA-day goal for a 510(k).

Ivoclar Vivadent, Inc. has 2 other decisions in the tracker over the last 12 months: K253953 (IPS e.max Zirconia), K252450 (Adhese 2).

Questions & Answers

What did FDA clear under K261485?

K261485 is the FDA 510(k) for Tetric plus Fill;Tetric plus Flow, submitted by Ivoclar Vivadent, Inc.. FDA's decision date was Jul 1, 2026, under product code EBF (Material, Tooth Shade, Resin).

Who makes the Tetric plus Fill;Tetric plus Flow?

Ivoclar Vivadent, Inc., based in Amherst, NY, is the applicant of record for K261485.

How long did the K261485 review take?

FDA received the submission on May 5, 2026 and issued its decision on Jul 1, 2026, 57 days later.

← All decisions in July 2026

Sources