Clearance Summary
BDC Dental Unit received FDA 510(k) clearance under submission number K242404, sponsored by Bdc Dental Corporation , 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 2025-02-07.
- Submission: K242404
- Applicant / Sponsor: Bdc Dental Corporation , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2025-02-07
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.