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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 / November 2025 / K252004

510(k) cleared

enCore Night Guard

Encore Guards · Nov 25, 2025 · K252004

FDA cleared the enCore Night Guard from Encore Guards on Nov 25, 2025 under K252004, 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 Jun 27, 2025. The decision came 151 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: K251926 (enCore Impression Material).

Questions & Answers

What did FDA clear under K252004?

K252004 is the FDA 510(k) for enCore Night Guard, submitted by Encore Guards. FDA's decision date was Nov 25, 2025, under product code OBR (Mouthguard, Over-The-Counter).

Who makes the enCore Night Guard?

Encore Guards, based in Santa Ana, CA, is the applicant of record for K252004.

How long did the K252004 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Nov 25, 2025, 151 days later.

← All decisions in November 2025