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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 / January 2026 / K252507

510(k) cleared

SmileInspector

Amv Consulting, LLC · Jan 7, 2026 · K252507

FDA cleared the SmileInspector from Amv Consulting, LLC on Jan 7, 2026 under K252507, 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 Aug 8, 2025. The decision came 152 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 Amv Consulting, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252507?

K252507 is the FDA 510(k) for SmileInspector, submitted by Amv Consulting, LLC. FDA's decision date was Jan 7, 2026, under product code PNN (Orthodontic Software).

Who makes the SmileInspector?

Amv Consulting, LLC, based in Bothell, WA, is the applicant of record for K252507.

How long did the K252507 review take?

FDA received the submission on Aug 8, 2025 and issued its decision on Jan 7, 2026, 152 days later.

← All decisions in January 2026