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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 / March 2026 / K260682

510(k) cleared

Bond-PR Universal Adhesive

Premier Dental Products Company · Mar 3, 2026 · K260682

FDA cleared the Bond-PR Universal Adhesive from Premier Dental Products Company on Mar 3, 2026 under K260682, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code KLE, Agent, Tooth Bonding, Resin, regulated at 21 CFR 872.3200 as a Class 2 device. The review panel was Dental.

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

Premier Dental Products Company has one other decision in the tracker over the last 12 months: K253513 (MultiMatch Flow Chameleon AntiMicrobial Composite).

Questions & Answers

What did FDA clear under K260682?

K260682 is the FDA 510(k) for Bond-PR Universal Adhesive, submitted by Premier Dental Products Company. FDA's decision date was Mar 3, 2026, under product code KLE (Agent, Tooth Bonding, Resin).

Who makes the Bond-PR Universal Adhesive?

Premier Dental Products Company, based in Plymouth Meeting, PA, is the applicant of record for K260682.

How long did the K260682 review take?

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

← All decisions in March 2026

Sources