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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 / K253798

510(k) cleared

UltraPrint-Dental Hard Splint UV

Guangzhou Heygears IMC., Inc. · Mar 2, 2026 · K253798

FDA cleared the UltraPrint-Dental Hard Splint UV from Guangzhou Heygears IMC., Inc. on Mar 2, 2026 under K253798, a traditional 510(k). The device falls under product code MQC, Mouthguard, Prescription as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Nov 28, 2025. The decision came 94 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Guangzhou Heygears IMC., Inc. has 2 other decisions in the tracker over the last 12 months: K261626 (UltraPrint Flexible Denture UV), K253324 (UltraPrint-Dental Denture UV).

Questions & Answers

What did FDA clear under K253798?

K253798 is the FDA 510(k) for UltraPrint-Dental Hard Splint UV, submitted by Guangzhou Heygears IMC., Inc.. FDA's decision date was Mar 2, 2026, under product code MQC (Mouthguard, Prescription).

Who makes the UltraPrint-Dental Hard Splint UV?

Guangzhou Heygears IMC., Inc., based in Guangzhou, is the applicant of record for K253798.

How long did the K253798 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Mar 2, 2026, 94 days later.

← All decisions in March 2026

Sources