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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 / April 2026 / K253804

510(k) cleared

DESS Dental Smart Solutions

Terrats Medical SL · Apr 16, 2026 · K253804

FDA cleared the DESS Dental Smart Solutions from Terrats Medical SL on Apr 16, 2026 under K253804, 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 Nov 28, 2025. The decision came 139 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: K260564 (DESS Dental Smart Solutions), K251547 (DESS Dental Smart Solutions), K252384 (DESS® Dental Smart Solutions).

Questions & Answers

What did FDA clear under K253804?

K253804 is the FDA 510(k) for DESS Dental Smart Solutions, submitted by Terrats Medical SL. FDA's decision date was Apr 16, 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 K253804.

How long did the K253804 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Apr 16, 2026, 139 days later.

← All decisions in April 2026

Sources