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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 / K260564

510(k) cleared

DESS Dental Smart Solutions

Terrats Medical SL · Jun 9, 2026 · K260564

FDA cleared the DESS Dental Smart Solutions from Terrats Medical SL on Jun 9, 2026 under K260564, 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 Feb 19, 2026. The decision came 110 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Terrats Medical SL has 3 other decisions in the tracker over the last 12 months: K253804 (DESS Dental Smart Solutions), K251547 (DESS Dental Smart Solutions), K252384 (DESS® Dental Smart Solutions).

Questions & Answers

What did FDA clear under K260564?

K260564 is the FDA 510(k) for DESS Dental Smart Solutions, submitted by Terrats Medical SL. FDA's decision date was Jun 9, 2026, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the DESS Dental Smart Solutions?

Terrats Medical SL, based in Barcelona, is the applicant of record for K260564.

How long did the K260564 review take?

FDA received the submission on Feb 19, 2026 and issued its decision on Jun 9, 2026, 110 days later.

← All decisions in June 2026

Sources