K231263
- 510(k) number
- K231263
- Device name
- Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT
- Applicant
- Prevest Denpro Limited IN
- Product code
- EBF — Material, Tooth Shade, Resin
- Decision date
- 2024-01-05
- Date received
- 2023-05-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K231263.pdf
Official FDA record: K231263
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.