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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 / K261474

510(k) cleared

DENTCA Tru Flexible

Dentca, Inc. · Jul 1, 2026 · K261474

FDA cleared the DENTCA Tru Flexible from Dentca, Inc. on Jul 1, 2026 under K261474, a traditional 510(k). The device falls under product code EBI, Resin, Denture, Relining, Repairing, Rebasing, regulated at 21 CFR 872.3760 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on May 4, 2026. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Dentca, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261474?

K261474 is the FDA 510(k) for DENTCA Tru Flexible, submitted by Dentca, Inc.. FDA's decision date was Jul 1, 2026, under product code EBI (Resin, Denture, Relining, Repairing, Rebasing).

Who makes the DENTCA Tru Flexible?

Dentca, Inc., based in Irvine, CA, is the applicant of record for K261474.

How long did the K261474 review take?

FDA received the submission on May 4, 2026 and issued its decision on Jul 1, 2026, 58 days later.

← All decisions in July 2026