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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 / September 2025 / K251206

510(k) cleared

Digital X-Ray DentiMax Pro Imaging System

Dentimax, Inc. · Sep 24, 2025 · K251206

FDA cleared the Digital X-Ray DentiMax Pro Imaging System from Dentimax, Inc. on Sep 24, 2025 under K251206, a traditional 510(k). The device falls under product code MUH, System, X-Ray, Extraoral Source, Digital, regulated at 21 CFR 872.1800 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Apr 18, 2025. The decision came 159 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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

Questions & Answers

What did FDA clear under K251206?

K251206 is the FDA 510(k) for Digital X-Ray DentiMax Pro Imaging System, submitted by Dentimax, Inc.. FDA's decision date was Sep 24, 2025, under product code MUH (System, X-Ray, Extraoral Source, Digital).

Who makes the Digital X-Ray DentiMax Pro Imaging System?

Dentimax, Inc., based in Mesa, AZ, is the applicant of record for K251206.

How long did the K251206 review take?

FDA received the submission on Apr 18, 2025 and issued its decision on Sep 24, 2025, 159 days later.

← All decisions in September 2025