K251884
- 510(k) number
- K251884
- Device name
- One-Fil Putty Injectable
- Applicant
- Mediclus Co., Ltd. KR
- Product code
- KIF — Resin, Root Canal Filling
- Decision date
- 2025-08-22
- Date received
- 2025-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251884.pdf
Official FDA record: K251884
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.