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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 / March 2026 / K251926

510(k) cleared

enCore Impression Material

Encore Guards · Mar 17, 2026 · K251926

FDA cleared the enCore Impression Material from Encore Guards on Mar 17, 2026 under K251926, a traditional 510(k). The device falls under product code SHI, Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter, regulated at 21 CFR 872.3660 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jun 23, 2025. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Encore Guards has one other decision in the tracker over the last 12 months: K252004 (enCore Night Guard).

Questions & Answers

What did FDA clear under K251926?

K251926 is the FDA 510(k) for enCore Impression Material, submitted by Encore Guards. FDA's decision date was Mar 17, 2026, under product code SHI (Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter).

Who makes the enCore Impression Material?

Encore Guards, based in Santa Ana, CA, is the applicant of record for K251926.

How long did the K251926 review take?

FDA received the submission on Jun 23, 2025 and issued its decision on Mar 17, 2026, 267 days later.

← All decisions in March 2026

Sources