Clearance Summary
ORAL-B SUB-BRAND MANUAL TOOTHBRUSH received FDA 510(k) clearance under submission number K073224, sponsored by Procter & Gamble. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2008-02-06.
- Submission: K073224
- Applicant / Sponsor: Procter & Gamble
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 2008-02-06
Classification & Regulation
This clearance is catalogued under FDA product code EFW and 21 CFR 872.6855, within the Dental review panel as a Class I device.