K241041
- 510(k) number
- K241041
- Device name
- Silver Fluoride Hypersensitivity Varnish
- Applicant
- Young Dental Manufacturing Co. 1, LLC MO · US
- Product code
- PHR — Diammine Silver Fluoride Dental Hypersensitivity Var
- Decision date
- 2025-02-28
- Date received
- 2024-04-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K241041.pdf
Official FDA record: K241041
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.