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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 / February 2026 / K251724

510(k) cleared

Remi Impression Material

Grindguard, Inc. · Feb 25, 2026 · K251724

FDA cleared the Remi Impression Material from Grindguard, Inc. on Feb 25, 2026 under K251724, 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 4, 2025. The decision came 266 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Grindguard, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251724?

K251724 is the FDA 510(k) for Remi Impression Material, submitted by Grindguard, Inc.. FDA's decision date was Feb 25, 2026, under product code SHI (Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter).

Who makes the Remi Impression Material?

Grindguard, Inc., based in San Francisco, CA, is the applicant of record for K251724.

How long did the K251724 review take?

FDA received the submission on Jun 4, 2025 and issued its decision on Feb 25, 2026, 266 days later.

← All decisions in February 2026