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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 / April 2026 / K260661

510(k) cleared

Midas Restore

Sprintray, Inc. · Apr 15, 2026 · K260661

FDA cleared the Midas Restore from Sprintray, Inc. on Apr 15, 2026 under K260661, a traditional 510(k). The device falls under product code EBF, Material, Tooth Shade, Resin, regulated at 21 CFR 872.3690 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Mar 2, 2026. The decision came 44 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K260661?

K260661 is the FDA 510(k) for Midas Restore, submitted by Sprintray, Inc.. FDA's decision date was Apr 15, 2026, under product code EBF (Material, Tooth Shade, Resin).

Who makes the Midas Restore?

Sprintray, Inc., based in Los Angeles, CA, is the applicant of record for K260661.

How long did the K260661 review take?

FDA received the submission on Mar 2, 2026 and issued its decision on Apr 15, 2026, 44 days later.

← All decisions in April 2026