Clearance Summary
PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER received FDA 510(k) clearance under submission number K896481, sponsored by Purebrush Assoc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1990-05-15.
- Submission: K896481
- Applicant / Sponsor: Purebrush Assoc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 1990-05-15
Classification & Regulation
This clearance is catalogued under FDA product code MCF and 21 CFR 872.6855, within the Dental review panel as a Class I device.