Clearance Summary
DENTO SPRAY ORAL IRRIGATOR received FDA 510(k) clearance under submission number K823305, sponsored by Neo-Life Co. of America. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1982-11-24.
- Submission: K823305
- Applicant / Sponsor: Neo-Life Co. of America
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6510
- Decision date: 1982-11-24
Classification & Regulation
This clearance is catalogued under FDA product code EFS and 21 CFR 872.6510, within the Dental review panel as a Class I device.