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 / November 2025 / K253365

510(k) cleared

LuxCreo Flexible Partial Denture Resin

LuxCreo, Inc. · Nov 25, 2025 · K253365

FDA cleared the LuxCreo Flexible Partial Denture Resin from LuxCreo, Inc. on Nov 25, 2025 under K253365, 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 56 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for LuxCreo, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253365?

K253365 is the FDA 510(k) for LuxCreo Flexible Partial Denture Resin, submitted by LuxCreo, Inc.. FDA's decision date was Nov 25, 2025, under product code EBI (Resin, Denture, Relining, Repairing, Rebasing).

Who makes the LuxCreo Flexible Partial Denture Resin?

LuxCreo, Inc., based in Chicago, IL, is the applicant of record for K253365.

How long did the K253365 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Nov 25, 2025, 56 days later.

← All decisions in November 2025