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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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: K261217 (AnyPlus II Spinal Fixation System), K254302 (ECG Analysis Software (AiTiALVSD)), K260250 (QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)), K243223 (Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)).

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