Clearance Summary
IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID received FDA 510(k) clearance under submission number K964271, sponsored by Airel-West. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1997-12-19.
- Submission: K964271
- Applicant / Sponsor: Airel-West
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1997-12-19
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.