Clearance Summary
Injectable Root Canal Bioceramic Sealer received FDA 510(k) clearance under submission number K212983, sponsored by Beijing C-Root Dental Medical Devices 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 2021-12-08.
- Submission: K212983
- Applicant / Sponsor: Beijing C-Root Dental Medical Devices Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3820
- Decision date: 2021-12-08
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.