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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 / K251188

510(k) cleared

UNIQA® Dental Implants System

Uniqa Dental, Ltd. · Jun 25, 2026 · K251188

FDA cleared the UNIQA® Dental Implants System from Uniqa Dental, Ltd. on Jun 25, 2026 under K251188, 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 17, 2025. The decision came 434 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 Uniqa Dental, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251188?

K251188 is the FDA 510(k) for UNIQA® Dental Implants System, submitted by Uniqa Dental, Ltd.. FDA's decision date was Jun 25, 2026, under product code DZE (Implant, Endosseous, Root-Form).

Who makes the UNIQA® Dental Implants System?

Uniqa Dental, Ltd., based in Netanya, is the applicant of record for K251188.

How long did the K251188 review take?

FDA received the submission on Apr 17, 2025 and issued its decision on Jun 25, 2026, 434 days later.

← All decisions in June 2026