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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 / January 2026 / K253973

510(k) cleared

Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series

Liaoning Upcera Co., Ltd. · Jan 9, 2026 · K253973

FDA cleared the Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series from Liaoning Upcera Co., Ltd. on Jan 9, 2026 under K253973, a special 510(k). The device falls under product code EIH, Powder, Porcelain, regulated at 21 CFR 872.6660 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Dec 11, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Liaoning Upcera Co., Ltd. has one other decision in the tracker over the last 12 months: K253380 (FLNT Base and FLNT Temp).

Questions & Answers

What did FDA clear under K253973?

K253973 is the FDA 510(k) for Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series, submitted by Liaoning Upcera Co., Ltd.. FDA's decision date was Jan 9, 2026, under product code EIH (Powder, Porcelain).

Who makes the Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series?

Liaoning Upcera Co., Ltd., based in Benxi, is the applicant of record for K253973.

How long did the K253973 review take?

FDA received the submission on Dec 11, 2025 and issued its decision on Jan 9, 2026, 29 days later.

← All decisions in January 2026

Sources