K240619
- 510(k) number
- K240619
- Device name
- e-SDF
- Applicant
- Kids-E-Dental Llp IN
- Product code
- PHR — Diammine Silver Fluoride Dental Hypersensitivity Var
- Decision date
- 2024-03-06
- Date received
- 2024-03-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K240619.pdf
Official FDA record: K240619
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.