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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 / January 2026 / K252890

510(k) cleared

ZenSeal Pro

Kerr Corporation · Jan 7, 2026 · K252890

FDA cleared the ZenSeal Pro from Kerr Corporation on Jan 7, 2026 under K252890, a traditional 510(k). The device falls under product code KIF, Resin, Root Canal Filling, regulated at 21 CFR 872.3820 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Sep 11, 2025. The decision came 118 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Kerr Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252890?

K252890 is the FDA 510(k) for ZenSeal Pro, submitted by Kerr Corporation. FDA's decision date was Jan 7, 2026, under product code KIF (Resin, Root Canal Filling).

Who makes the ZenSeal Pro?

Kerr Corporation, based in Pomona, CA, is the applicant of record for K252890.

How long did the K252890 review take?

FDA received the submission on Sep 11, 2025 and issued its decision on Jan 7, 2026, 118 days later.

← All decisions in January 2026