Clearance Summary
FEEL FRESH TOOTHBRUSH KIT received FDA 510(k) clearance under submission number K905090, sponsored by Fresh Appeal , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1991-01-25.
- Submission: K905090
- Applicant / Sponsor: Fresh Appeal , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 1991-01-25
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.