Clearance Summary
CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS) received FDA 510(k) clearance under submission number K002693, sponsored by Cbs Intl. B.V.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-11-09.
- Submission: K002693
- Applicant / Sponsor: Cbs Intl. B.V.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3740
- Decision date: 2000-11-09
Classification & Regulation
This clearance is catalogued under FDA product code EBL and 21 CFR 872.3740, within the Dental review panel as a Class I device.