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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 / K253334

510(k) cleared

ZENEX Implant System_Short (R-System)

Izenimplant Co., Ltd. · Mar 16, 2026 · K253334

FDA cleared the ZENEX Implant System_Short (R-System) from Izenimplant Co., Ltd. on Mar 16, 2026 under K253334, a traditional 510(k). The device falls under product code DZE, Implant, Endosseous, Root-Form, regulated at 21 CFR 872.3640 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Sep 30, 2025. The decision came 167 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Izenimplant Co., Ltd. has one other decision in the tracker over the last 12 months: K252585 (ZENEX Implant System_R-System).

Questions & Answers

What did FDA clear under K253334?

K253334 is the FDA 510(k) for ZENEX Implant System_Short (R-System), submitted by Izenimplant Co., Ltd.. FDA's decision date was Mar 16, 2026, under product code DZE (Implant, Endosseous, Root-Form).

Who makes the ZENEX Implant System_Short (R-System)?

Izenimplant Co., Ltd., based in Pyeongtaek-Si, is the applicant of record for K253334.

How long did the K253334 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Mar 16, 2026, 167 days later.

← All decisions in March 2026

Sources