K242934
- 510(k) number
- K242934
- Device name
- Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)
- Applicant
- Longly Biotechnology (Wuhan) Co., Ltd. CN
- Product code
- KIF — Resin, Root Canal Filling
- Decision date
- 2024-12-12
- Date received
- 2024-09-25
- 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: K242934.pdf
Official FDA record: K242934
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.