K231142
- 510(k) number
- K231142
- Device name
- Temporis, Irix Plus
- Applicant
- Dws S.R.L. IT
- Product code
- EBF — Material, Tooth Shade, Resin
- Decision date
- 2024-04-25
- Date received
- 2023-04-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K231142.pdf
Official FDA record: K231142
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.