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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 / K253641

510(k) cleared

Owl Night Guard

Owl Dental Lab, Inc. · Feb 26, 2026 · K253641

FDA cleared the Owl Night Guard from Owl Dental Lab, Inc. on Feb 26, 2026 under K253641, a traditional 510(k). The device falls under product code OBR, Mouthguard, Over-The-Counter as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Nov 19, 2025. The decision came 99 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 Owl Dental Lab, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253641?

K253641 is the FDA 510(k) for Owl Night Guard, submitted by Owl Dental Lab, Inc.. FDA's decision date was Feb 26, 2026, under product code OBR (Mouthguard, Over-The-Counter).

Who makes the Owl Night Guard?

Owl Dental Lab, Inc., based in San Leandro, CA, is the applicant of record for K253641.

How long did the K253641 review take?

FDA received the submission on Nov 19, 2025 and issued its decision on Feb 26, 2026, 99 days later.

← All decisions in February 2026