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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 / February 2026 / K251515

510(k) cleared

Solidex® Ti-Links and Screws

CreoDent Hudson Valley · Feb 10, 2026 · K251515

FDA cleared the Solidex® Ti-Links and Screws from CreoDent Hudson Valley on Feb 10, 2026 under K251515, a traditional 510(k). The device falls under product code NHA, Abutment, Implant, Dental, Endosseous, regulated at 21 CFR 872.3630 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on May 16, 2025. The decision came 270 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 CreoDent Hudson Valley in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251515?

K251515 is the FDA 510(k) for Solidex® Ti-Links and Screws, submitted by CreoDent Hudson Valley. FDA's decision date was Feb 10, 2026, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the Solidex® Ti-Links and Screws?

CreoDent Hudson Valley, based in Fishkill, NY, is the applicant of record for K251515.

How long did the K251515 review take?

FDA received the submission on May 16, 2025 and issued its decision on Feb 10, 2026, 270 days later.

← All decisions in February 2026