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 / July 2026 / K260851

510(k) cleared

Better Diagnostics Dental Assist (BDDA) Version 1.0

Better Diagnostics AI Corp. · Jul 15, 2026 · K260851

FDA cleared the Better Diagnostics Dental Assist (BDDA) Version 1.0 from Better Diagnostics AI Corp. on Jul 15, 2026 under K260851, a traditional 510(k). The device falls under product code MYN, Analyzer, Medical Image, regulated at 21 CFR 892.2070 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 16, 2026. The decision came 121 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 Better Diagnostics AI Corp. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260851?

K260851 is the FDA 510(k) for Better Diagnostics Dental Assist (BDDA) Version 1.0, submitted by Better Diagnostics AI Corp.. FDA's decision date was Jul 15, 2026, under product code MYN (Analyzer, Medical Image).

Who makes the Better Diagnostics Dental Assist (BDDA) Version 1.0?

Better Diagnostics AI Corp., based in Avon, CT, is the applicant of record for K260851.

How long did the K260851 review take?

FDA received the submission on Mar 16, 2026 and issued its decision on Jul 15, 2026, 121 days later.

← All decisions in July 2026