K251465
- 510(k) number
- K251465
- Device name
- Root canal repair materials (nRoot BP)
- Applicant
- Enpuno Biotechnology Co., Ltd. CN
- Product code
- KIF — Resin, Root Canal Filling
- Decision date
- 2025-09-25
- Date received
- 2025-05-13
- 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: K251465.pdf
Official FDA record: K251465
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.