K222459
- 510(k) number
- K222459
- Device name
- Centrix FluoroSilver Silver Diamine Fluoride 38%
- Applicant
- Centrix, Inc. CT · US
- Product code
- PHR — Diammine Silver Fluoride Dental Hypersensitivity Var
- Decision date
- 2023-10-27
- Date received
- 2022-08-15
- 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: K222459.pdf
Official FDA record: K222459
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.