K241977
- 510(k) number
- K241977
- Device name
- Injectable Root Canal Bioceramic Sealer (i-MTA SP)
- Applicant
- Longly Biotechnology (Wuhan) Co., Ltd. CN
- Product code
- KIF — Resin, Root Canal Filling
- Decision date
- 2024-10-03
- Date received
- 2024-07-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K241977.pdf
Official FDA record: K241977
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.