Clearance Summary
COLGATE DENTAL FLOSS received FDA 510(k) clearance under submission number K883335, sponsored by Colgate-Palmolive Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1988-08-26.
- Submission: K883335
- Applicant / Sponsor: Colgate-Palmolive Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6390
- Decision date: 1988-08-26
Classification & Regulation
This clearance is catalogued under FDA product code JES and 21 CFR 872.6390, within the Dental review panel as a Class I device.