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THE TAPE

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 / April 2026 / K260082

510(k) cleared

TRIOS Dx (R1)

3Shape TRIOS A/S · Apr 10, 2026 · K260082

FDA cleared the TRIOS Dx (R1) from 3Shape TRIOS A/S on Apr 10, 2026 under K260082, a traditional 510(k). The device falls under product code SHQ, Dental Image Analyzer, In-Office, regulated at 21 CFR 872.1770 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jan 12, 2026. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for 3Shape TRIOS A/S in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260082?

K260082 is the FDA 510(k) for TRIOS Dx (R1), submitted by 3Shape TRIOS A/S. FDA's decision date was Apr 10, 2026, under product code SHQ (Dental Image Analyzer, In-Office).

Who makes the TRIOS Dx (R1)?

3Shape TRIOS A/S, based in Copenhagen, is the applicant of record for K260082.

How long did the K260082 review take?

FDA received the submission on Jan 12, 2026 and issued its decision on Apr 10, 2026, 88 days later.

← All decisions in April 2026