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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 / K253493

510(k) cleared

Dentis SQ-SL AXEL Fixture

Dentis Co., Ltd. · Mar 4, 2026 · K253493

FDA cleared the Dentis SQ-SL AXEL Fixture from Dentis Co., Ltd. on Mar 4, 2026 under K253493, 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 Oct 27, 2025. The decision came 128 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 Dentis Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253493?

K253493 is the FDA 510(k) for Dentis SQ-SL AXEL Fixture, submitted by Dentis Co., Ltd.. FDA's decision date was Mar 4, 2026, under product code DZE (Implant, Endosseous, Root-Form).

Who makes the Dentis SQ-SL AXEL Fixture?

Dentis Co., Ltd., based in Dalseo-Gu, is the applicant of record for K253493.

How long did the K253493 review take?

FDA received the submission on Oct 27, 2025 and issued its decision on Mar 4, 2026, 128 days later.

← All decisions in March 2026