Clearance Summary
ORAL-B ULTRAFLOSS WITH FLLUORIDE received FDA 510(k) clearance under submission number K943157, sponsored by Oral-B Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1995-04-27.
- Submission: K943157
- Applicant / Sponsor: Oral-B Laboratories
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6390
- Decision date: 1995-04-27
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.