Clearance Summary
CLEANAIR/ CLEANWATER UNIT, MODEL 1600 received FDA 510(k) clearance under submission number K003265, sponsored by Texas Institute For Conservative Dentistry. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-12-22.
- Submission: K003265
- Applicant / Sponsor: Texas Institute For Conservative Dentistry
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2000-12-22
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.