K240304
- 510(k) number
- K240304
- Device name
- Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)
- Applicant
- Enpuno Biotechnology Co., Ltd. CN
- Product code
- KIF — Resin, Root Canal Filling
- Decision date
- 2024-05-28
- Date received
- 2024-02-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240304.pdf
Official FDA record: K240304
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.