Clearance Summary
QUADRANT UNIBOND received FDA 510(k) clearance under submission number K983545, sponsored by Cavex Holland BV. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1998-11-18.
- Submission: K983545
- Applicant / Sponsor: Cavex Holland BV
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3200
- Decision date: 1998-11-18
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.