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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 / K251232

510(k) cleared

MegaGen Zygoma Dental Implant System

Megagen Implant Co., Ltd. · Jun 18, 2026 · K251232

FDA cleared the MegaGen Zygoma Dental Implant System from Megagen Implant Co., Ltd. on Jun 18, 2026 under K251232, 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 Apr 22, 2025. The decision came 422 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 Megagen Implant Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251232?

K251232 is the FDA 510(k) for MegaGen Zygoma Dental Implant System, submitted by Megagen Implant Co., Ltd.. FDA's decision date was Jun 18, 2026, under product code DZE (Implant, Endosseous, Root-Form).

Who makes the MegaGen Zygoma Dental Implant System?

Megagen Implant Co., Ltd., based in Deagu, is the applicant of record for K251232.

How long did the K251232 review take?

FDA received the submission on Apr 22, 2025 and issued its decision on Jun 18, 2026, 422 days later.

← All decisions in June 2026