Clearance Summary
LISTERINE Sensitivity Defense Mouthrinse received FDA 510(k) clearance under submission number K143155, sponsored by Johnson & Johnson Healthcare Products, Division of Mcneil-Pp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2015-01-29.
- Submission: K143155
- Applicant / Sponsor: Johnson & Johnson Healthcare Products, Division of Mcneil-Pp
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3260
- Decision date: 2015-01-29
Classification & Regulation
This clearance is catalogued under FDA product code LBH and 21 CFR 872.3260, within the Dental review panel as a Class II device.