K232182
- 510(k) number
- K232182
- Device name
- One-Fil
- Applicant
- Mediclus Co., Ltd. KR
- Product code
- KIF — Resin, Root Canal Filling
- Decision date
- 2024-01-26
- Date received
- 2023-07-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K232182.pdf
Official FDA record: K232182
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.