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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 / June 2026 / K261826

510(k) cleared

VSP System (Titanium Palatal Splint)

3D Systems, Inc. · Jun 3, 2026 · K261826

FDA cleared the VSP System (Titanium Palatal Splint) from 3D Systems, Inc. on Jun 3, 2026 under K261826, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code DZJ, Driver, Wire, And Bone Drill, Manual, regulated at 21 CFR 872.4120 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jun 1, 2026. The decision came 2 days later, inside the 90 FDA-day goal for a 510(k).

3D Systems, Inc. has 8 other decisions in the tracker over the last 12 months: K253808 (AIR Recon DL), K253667 (Accoat Guide Wire), K254130 (C.A. Medical Interbody Fusion System), K253317 (Cytrans Elashield).

Questions & Answers

What did FDA clear under K261826?

K261826 is the FDA 510(k) for VSP System (Titanium Palatal Splint), submitted by 3D Systems, Inc.. FDA's decision date was Jun 3, 2026, under product code DZJ (Driver, Wire, And Bone Drill, Manual).

Who makes the VSP System (Titanium Palatal Splint)?

3D Systems, Inc., based in Littleton, CO, is the applicant of record for K261826.

How long did the K261826 review take?

FDA received the submission on Jun 1, 2026 and issued its decision on Jun 3, 2026, 2 days later.

← All decisions in June 2026