Clearance Summary
BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER received FDA 510(k) clearance under submission number K992435, sponsored by Azo Enterprises. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1999-10-15.
- Submission: K992435
- Applicant / Sponsor: Azo Enterprises
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 1999-10-15
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.