Clearance Summary
DENTAL FLOSS received FDA 510(k) clearance under submission number K912430, sponsored by Westone Products , 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 1991-09-30.
- Submission: K912430
- Applicant / Sponsor: Westone Products , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6390
- Decision date: 1991-09-30
Classification & Regulation
This clearance is catalogued under FDA product code JES and 21 CFR 872.6390, within the Dental review panel as a Class I device.