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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 / K253324

510(k) cleared

UltraPrint-Dental Denture UV

Guangzhou Heygears IMC., Inc. · Nov 20, 2025 · K253324

FDA cleared the UltraPrint-Dental Denture UV from Guangzhou Heygears IMC., Inc. on Nov 20, 2025 under K253324, a traditional 510(k). The device falls under product code EBI, Resin, Denture, Relining, Repairing, Rebasing, regulated at 21 CFR 872.3760 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Sep 30, 2025. The decision came 51 days later, inside the 90 FDA-day goal for a 510(k).

Guangzhou Heygears IMC., Inc. has 2 other decisions in the tracker over the last 12 months: K261626 (UltraPrint Flexible Denture UV), K253798 (UltraPrint-Dental Hard Splint UV).

Questions & Answers

What did FDA clear under K253324?

K253324 is the FDA 510(k) for UltraPrint-Dental Denture UV, submitted by Guangzhou Heygears IMC., Inc.. FDA's decision date was Nov 20, 2025, under product code EBI (Resin, Denture, Relining, Repairing, Rebasing).

Who makes the UltraPrint-Dental Denture UV?

Guangzhou Heygears IMC., Inc., based in Guangzhou, is the applicant of record for K253324.

How long did the K253324 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Nov 20, 2025, 51 days later.

← All decisions in November 2025

Sources