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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 / October 2025 / K251497

510(k) cleared

Elos Accurate Hybrid Base

Elos Medtech Pinol A/S · Oct 16, 2025 · K251497

FDA cleared the Elos Accurate Hybrid Base from Elos Medtech Pinol A/S on Oct 16, 2025 under K251497, 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 May 15, 2025. The decision came 154 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: K253774 (Elos Accurate® Denture Fixation System).

Questions & Answers

What did FDA clear under K251497?

K251497 is the FDA 510(k) for Elos Accurate Hybrid Base, submitted by Elos Medtech Pinol A/S. FDA's decision date was Oct 16, 2025, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the Elos Accurate Hybrid Base?

Elos Medtech Pinol A/S, based in Goerloese, is the applicant of record for K251497.

How long did the K251497 review take?

FDA received the submission on May 15, 2025 and issued its decision on Oct 16, 2025, 154 days later.

← All decisions in October 2025

Sources