Clearance Summary
REACH ANTIBACTERIAL TOOTHBRUSH received FDA 510(k) clearance under submission number K971589, sponsored by Personal Products 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 1997-07-24.
- Submission: K971589
- Applicant / Sponsor: Personal Products Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 1997-07-24
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.