K240365
- 510(k) number
- K240365
- Device name
- Bioceramic Root Repair Material (C-Root BP)
- Applicant
- Beijing C-Root Dental Medical Devices Co., Ltd. CN
- Product code
- KIF — Resin, Root Canal Filling
- Decision date
- 2024-05-10
- Date received
- 2024-02-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K240365.pdf
Official FDA record: K240365
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.