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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 / K262228

510(k) cleared

Transcend Bulk Fill Flowable Composite

Ultradent Products, Inc. · Jul 1, 2026 · K262228

FDA cleared the Transcend Bulk Fill Flowable Composite from Ultradent Products, Inc. on Jul 1, 2026 under K262228, 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 Jun 30, 2026. The decision came 1 days later, inside the 90 FDA-day goal for a 510(k).

Ultradent Products, Inc. has one other decision in the tracker over the last 12 months: K261404 (UltraEZ).

Questions & Answers

What did FDA clear under K262228?

K262228 is the FDA 510(k) for Transcend Bulk Fill Flowable Composite, submitted by Ultradent Products, Inc.. FDA's decision date was Jul 1, 2026, under product code EBF (Material, Tooth Shade, Resin).

Who makes the Transcend Bulk Fill Flowable Composite?

Ultradent Products, Inc., based in South Jordan, UT, is the applicant of record for K262228.

How long did the K262228 review take?

FDA received the submission on Jun 30, 2026 and issued its decision on Jul 1, 2026, 1 days later.

← All decisions in July 2026

Sources