Clearance Summary
VACUDENT LUMIX 70 received FDA 510(k) clearance under submission number K800575, sponsored by Vacudent Sales Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1980-05-20.
- Submission: K800575
- Applicant / Sponsor: Vacudent Sales Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3285
- Decision date: 1980-05-20
Classification & Regulation
This clearance is catalogued under FDA product code EHP and 21 CFR 872.3285, within the Dental review panel as a Class I device.