Clearance Summary
Injectable Root Canal Bioceramic Sealer (i-MTA SP) received FDA 510(k) clearance under submission number K241977, sponsored by Longly Biotechnology (Wuhan) Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2024-10-03.
- Submission: K241977
- Applicant / Sponsor: Longly Biotechnology (Wuhan) Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3820
- Decision date: 2024-10-03
Classification & Regulation
This clearance is catalogued under FDA product code KIF and 21 CFR 872.3820, within the Dental review panel as a Class II device.