K250714
- 510(k) number
- K250714
- Device name
- FluoroDose Varnish
- Applicant
- Centrix, Inc. CT · US
- Product code
- LBH — Varnish, Cavity
- Decision date
- 2025-11-21
- Date received
- 2025-03-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250714.pdf
Official FDA record: K250714
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.