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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 / August 2026 / K261626

510(k) cleared

UltraPrint Flexible Denture UV

Guangzhou Heygears IMC., Inc. · Aug 13, 2026 · K261626

FDA cleared the UltraPrint Flexible Denture UV from Guangzhou Heygears IMC., Inc. on Aug 13, 2026 under K261626, 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 May 15, 2026. The decision came 90 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: K253798 (UltraPrint-Dental Hard Splint UV), K253324 (UltraPrint-Dental Denture UV).

Questions & Answers

What did FDA clear under K261626?

K261626 is the FDA 510(k) for UltraPrint Flexible Denture UV, submitted by Guangzhou Heygears IMC., Inc.. FDA's decision date was Aug 13, 2026, under product code EBI (Resin, Denture, Relining, Repairing, Rebasing).

Who makes the UltraPrint Flexible Denture UV?

Guangzhou Heygears IMC., Inc., based in Guangzhou, is the applicant of record for K261626.

How long did the K261626 review take?

FDA received the submission on May 15, 2026 and issued its decision on Aug 13, 2026, 90 days later.

← All decisions in August 2026

Sources