Clearance Summary
SIMPLIFLOS DENTAL FLOSSER received FDA 510(k) clearance under submission number K844438, sponsored by Valiant Steel & Equipment, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1985-01-04.
- Submission: K844438
- Applicant / Sponsor: Valiant Steel & Equipment, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6390
- Decision date: 1985-01-04
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.