Clearance Summary
DX. Bond V Dental Bonding Adhesive received FDA 510(k) clearance under submission number K232978, sponsored by Sino-Dentex 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 2023-09-22.
- Submission: K232978
- Applicant / Sponsor: Sino-Dentex Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3200
- Decision date: 2023-09-22
Classification & Regulation
This clearance is catalogued under FDA product code KLE and 21 CFR 872.3200, within the Dental review panel as a Class II device.