Skip to the page

Data / Medical devices / United States / Better Diagnostics Ai Corp

Better Diagnostics Ai Corp: FDA-registered device maker in Avon, CT, United States, 1 510(k) clearance

Better Diagnostics Ai Corp is registered with the FDA (registration 3038172231) in Avon, CT, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 11, 2025. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number
3038172231
Address
29 Alcott Way #ALC029, Avon, CT, United States, 06001
Owner or operator
BETTER DIAGNOSTICS AI CORP (10093340)
Roles
Manufacturer
First device listed
May 2, 2025
Registered through
2026
Brand names listed
Better Diagnostics Caries Assist (BDCA) Version 1

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Medical ImageMYN2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 11, 2025K241725Better Diagnostics Caries Assist (BDCA) Version 1.0MYNSubstantially EquivalentBetter Diagnostics AI Corp.accessdata.fda.gov

Compare with other makers

Updated March 11, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.