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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 / K243732

510(k) cleared

Multi-Unit DAS System

Talladium España, SL · Jan 29, 2026 · K243732

FDA cleared the Multi-Unit DAS System from Talladium España, SL on Jan 29, 2026 under K243732, a traditional 510(k). The device falls under product code NHA, Abutment, Implant, Dental, Endosseous, regulated at 21 CFR 872.3630 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Dec 4, 2024. The decision came 421 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 Talladium España, SL in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243732?

K243732 is the FDA 510(k) for Multi-Unit DAS System, submitted by Talladium España, SL. FDA's decision date was Jan 29, 2026, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the Multi-Unit DAS System?

Talladium España, SL, based in Lleida, is the applicant of record for K243732.

How long did the K243732 review take?

FDA received the submission on Dec 4, 2024 and issued its decision on Jan 29, 2026, 421 days later.

← All decisions in January 2026