Clearance Summary
Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu received FDA 510(k) clearance under submission number K233954, sponsored by B&E Korea 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 2024-02-13.
- Submission: K233954
- Applicant / Sponsor: B&E Korea Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 2024-02-13
Classification & Regulation
This clearance is catalogued under FDA product code ELW and 21 CFR 872.3660, within the Dental review panel as a Class II device.