Clearance Summary
JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED received FDA 510(k) clearance under submission number K935440, sponsored by Johnson & Johnson Consumer Products, 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 1994-02-03.
- Submission: K935440
- Applicant / Sponsor: Johnson & Johnson Consumer Products, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6390
- Decision date: 1994-02-03
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.