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THE TAPE

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 / K252450

510(k) cleared

Adhese 2

Ivoclar Vivadent, Inc. · Mar 5, 2026 · K252450

FDA cleared the Adhese 2 from Ivoclar Vivadent, Inc. on Mar 5, 2026 under K252450, a traditional 510(k). 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 Aug 4, 2025. The decision came 213 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ivoclar Vivadent, Inc. has 2 other decisions in the tracker over the last 12 months: K261485 (Tetric plus Fill;Tetric plus Flow), K253953 (IPS e.max Zirconia).

Questions & Answers

What did FDA clear under K252450?

K252450 is the FDA 510(k) for Adhese 2, submitted by Ivoclar Vivadent, Inc.. FDA's decision date was Mar 5, 2026, under product code KLE (Agent, Tooth Bonding, Resin).

Who makes the Adhese 2?

Ivoclar Vivadent, Inc., based in Amherst, NY, is the applicant of record for K252450.

How long did the K252450 review take?

FDA received the submission on Aug 4, 2025 and issued its decision on Mar 5, 2026, 213 days later.

← All decisions in March 2026

Sources