K240059
- 510(k) number
- K240059
- Device name
- FAgamin®
- Applicant
- Tedequim Srl AR
- Product code
- PHR — Diammine Silver Fluoride Dental Hypersensitivity Var
- Decision date
- 2024-05-16
- Date received
- 2024-01-08
- 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: K240059.pdf
Official FDA record: K240059
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.