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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 / December 2025 / K253343

510(k) cleared

Celebrace Software

Celebrace · Dec 29, 2025 · K253343

FDA cleared the Celebrace Software from Celebrace on Dec 29, 2025 under K253343, a traditional 510(k). The device falls under product code PNN, Orthodontic Software, regulated at 21 CFR 872.5470 as a Class 2 device. The review panel was Dental.

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

This is the only decision on file for Celebrace in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253343?

K253343 is the FDA 510(k) for Celebrace Software, submitted by Celebrace. FDA's decision date was Dec 29, 2025, under product code PNN (Orthodontic Software).

Who makes the Celebrace Software?

Celebrace, based in Colleyville, TX, is the applicant of record for K253343.

How long did the K253343 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Dec 29, 2025, 90 days later.

← All decisions in December 2025