Clearance Summary
CLINI-DENT received FDA 510(k) clearance under submission number K000140, sponsored by The Precident Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-05-03.
- Submission: K000140
- Applicant / Sponsor: The Precident Group
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 2000-05-03
Classification & Regulation
This clearance is catalogued under FDA product code MAU and 21 CFR 872.6855, within the Dental review panel as a Class I device.