K260851
- 510(k) number
- K260851
- Device name
- Better Diagnostics Dental Assist (BDDA) Version 1.0
- Applicant
- Better Diagnostics AI Corp. CT · US
- Product code
- MYN — Analyzer, Medical Image
- Decision date
- 2026-07-15
- Date received
- 2026-03-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K260851.pdf
Official FDA record: K260851
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.