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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 / May 2026 / K253774

510(k) cleared

Elos Accurate® Denture Fixation System

Elos Medtech Pinol A/S · May 20, 2026 · K253774

FDA cleared the Elos Accurate® Denture Fixation System from Elos Medtech Pinol A/S on May 20, 2026 under K253774, 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 26, 2025. The decision came 175 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Elos Medtech Pinol A/S has one other decision in the tracker over the last 12 months: K251497 (Elos Accurate Hybrid Base).

Questions & Answers

What did FDA clear under K253774?

K253774 is the FDA 510(k) for Elos Accurate® Denture Fixation System, submitted by Elos Medtech Pinol A/S. FDA's decision date was May 20, 2026, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the Elos Accurate® Denture Fixation System?

Elos Medtech Pinol A/S, based in Goerloese, is the applicant of record for K253774.

How long did the K253774 review take?

FDA received the submission on Nov 26, 2025 and issued its decision on May 20, 2026, 175 days later.

← All decisions in May 2026

Sources