Clearance Summary
VECTOR F SERIES HIGH-SPEED DENTAL HANDPIECES received FDA 510(k) clearance under submission number K020113, sponsored by Vector Research & Development. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2002-05-17.
- Submission: K020113
- Applicant / Sponsor: Vector Research & Development
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 2002-05-17
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.