Clearance Summary
Oral-B iO Test Drive Power Brush Trial Program Kit received FDA 510(k) clearance under submission number K200881, sponsored by The Procter & Gamble Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2020-08-27.
- Submission: K200881
- Applicant / Sponsor: The Procter & Gamble Company
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6865
- Decision date: 2020-08-27
Classification & Regulation
This clearance is catalogued under FDA product code JEQ and 21 CFR 872.6865, within the Dental review panel as a Class I device.