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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 / K261840

510(k) cleared

BracePaste Prime Plus

American Orthodontics · Jun 3, 2026 · K261840

FDA cleared the BracePaste Prime Plus from American Orthodontics on Jun 3, 2026 under K261840, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code DYH, Adhesive, Bracket And Tooth Conditioner, Resin, regulated at 21 CFR 872.3750 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jun 2, 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 American Orthodontics in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261840?

K261840 is the FDA 510(k) for BracePaste Prime Plus, submitted by American Orthodontics. FDA's decision date was Jun 3, 2026, under product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin).

Who makes the BracePaste Prime Plus?

American Orthodontics, based in Sheboygan, WI, is the applicant of record for K261840.

How long did the K261840 review take?

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

← All decisions in June 2026