K250710
- 510(k) number
- K250710
- Device name
- Injectable Root Canal Bioceramic Sealer (nRoot SP)
- Applicant
- Enpuno Co., Ltd. CN
- Product code
- KIF — Resin, Root Canal Filling
- Decision date
- 2025-06-11
- Date received
- 2025-03-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K250710.pdf
Official FDA record: K250710
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.