Clearance Summary
BELMONT QUOLIS 5000 SERIES DENTAL UNIT received FDA 510(k) clearance under submission number K072273, sponsored by Takara Belmont USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2007-12-20.
- Submission: K072273
- Applicant / Sponsor: Takara Belmont USA, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2007-12-20
Classification & Regulation
This clearance is catalogued under FDA product code NRD and 21 CFR 872.6640, within the Dental review panel as a Class I device.