Clearance Summary
BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES received FDA 510(k) clearance under submission number K022900, sponsored by John O. Butler 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 2002-11-14.
- Submission: K022900
- Applicant / Sponsor: John O. Butler Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6865
- Decision date: 2002-11-14
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.