WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K253380

510(k) cleared

FLNT Base and FLNT Temp

Liaoning Upcera Co., Ltd. · Mar 2, 2026 · K253380

FDA cleared the FLNT Base and FLNT Temp from Liaoning Upcera Co., Ltd. on Mar 2, 2026 under K253380, a traditional 510(k). The device falls under product code EBG, Crown And Bridge, Temporary, Resin, regulated at 21 CFR 872.3770 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Sep 30, 2025. The decision came 153 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Liaoning Upcera Co., Ltd. has one other decision in the tracker over the last 12 months: K253973 (Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series).

Questions & Answers

What did FDA clear under K253380?

K253380 is the FDA 510(k) for FLNT Base and FLNT Temp, submitted by Liaoning Upcera Co., Ltd.. FDA's decision date was Mar 2, 2026, under product code EBG (Crown And Bridge, Temporary, Resin).

Who makes the FLNT Base and FLNT Temp?

Liaoning Upcera Co., Ltd., based in Benxi, is the applicant of record for K253380.

How long did the K253380 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Mar 2, 2026, 153 days later.

← All decisions in March 2026

Sources