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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 / November 2025 / K250739

510(k) cleared

Primeprint Direct Aligner

Dreve Dentamid GmbH · Nov 7, 2025 · K250739

FDA cleared the Primeprint Direct Aligner from Dreve Dentamid GmbH on Nov 7, 2025 under K250739, a traditional 510(k). The device falls under product code NXC, Aligner, Sequential, regulated at 21 CFR 872.5470 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Mar 11, 2025. The decision came 241 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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

Questions & Answers

What did FDA clear under K250739?

K250739 is the FDA 510(k) for Primeprint Direct Aligner, submitted by Dreve Dentamid GmbH. FDA's decision date was Nov 7, 2025, under product code NXC (Aligner, Sequential).

Who makes the Primeprint Direct Aligner?

Dreve Dentamid GmbH, based in Unna, is the applicant of record for K250739.

How long did the K250739 review take?

FDA received the submission on Mar 11, 2025 and issued its decision on Nov 7, 2025, 241 days later.

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