K230144
- 510(k) number
- K230144
- Device name
- Denti.AI Detect
- Applicant
- Denti.Ai Technology, Inc. CA
- Product code
- MYN — Analyzer, Medical Image
- Decision date
- 2023-10-06
- Date received
- 2023-01-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K230144.pdf
Official FDA record: K230144
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.