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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 / October 2025 / K252430

510(k) cleared

Freeprint® denture flex

Detax GmbH · Oct 30, 2025 · K252430

FDA cleared the Freeprint® denture flex from Detax GmbH on Oct 30, 2025 under K252430, 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 Aug 1, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Detax GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252430?

K252430 is the FDA 510(k) for Freeprint® denture flex, submitted by Detax GmbH. FDA's decision date was Oct 30, 2025, under product code EBI (Resin, Denture, Relining, Repairing, Rebasing).

Who makes the Freeprint® denture flex?

Detax GmbH, based in Ettingen, is the applicant of record for K252430.

How long did the K252430 review take?

FDA received the submission on Aug 1, 2025 and issued its decision on Oct 30, 2025, 90 days later.

← All decisions in October 2025