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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 / K262300

510(k) cleared

Denture Base Resin V2

Formlabs Ohio, Inc. · Jul 8, 2026 · K262300

FDA cleared the Denture Base Resin V2 from Formlabs Ohio, Inc. on Jul 8, 2026 under K262300, a abbreviated 510(k) reviewed through the Third Party Review Program. 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 Jul 7, 2026. The decision came 1 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K262300?

K262300 is the FDA 510(k) for Denture Base Resin V2, submitted by Formlabs Ohio, Inc.. FDA's decision date was Jul 8, 2026, under product code EBI (Resin, Denture, Relining, Repairing, Rebasing).

Who makes the Denture Base Resin V2?

Formlabs Ohio, Inc., based in Millbury, OH, is the applicant of record for K262300.

How long did the K262300 review take?

FDA received the submission on Jul 7, 2026 and issued its decision on Jul 8, 2026, 1 days later.

← All decisions in July 2026