Clearance Summary
MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT received FDA 510(k) clearance under submission number K983847, sponsored by Germiphene 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 1998-12-01.
- Submission: K983847
- Applicant / Sponsor: Germiphene Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1998-12-01
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.