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.
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- 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
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Medical Image | MYN | 2 | Manufacturer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 11, 2025 | K241725 | Better Diagnostics Caries Assist (BDCA) Version 1.0 | MYN | Substantially Equivalent | Better 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.