Clearance Summary
QUADRANT TOTAL ETCH received FDA 510(k) clearance under submission number K984043, 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 1998-12-04.
- Submission: K984043
- Applicant / Sponsor: Cavex Holland BV
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 1998-12-04
Classification & Regulation
This clearance is catalogued under FDA product code EBF and 21 CFR 872.3690, within the Dental review panel as a Class II device.