Clearance Summary
BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES received FDA 510(k) clearance under submission number K983661, sponsored by Belmont Equipment 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 1999-01-12.
- Submission: K983661
- Applicant / Sponsor: Belmont Equipment Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1999-01-12
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.