meddevicedb.com FDA Device Reference

Oral-B Dry Mouth Oral Rinse

K201277 Traditional
Decision Date
2020-09-02
Sponsor / Applicant
The Procter & Gamble Company

Technical Specification

510(k) Submission ID K201277
Product Code LFD
Medical Specialty / Panel Unknown
Decision Date 2020-09-02
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Oral-B Dry Mouth Oral Rinse received FDA 510(k) clearance under submission number K201277, sponsored by The Procter & Gamble Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2020-09-02.

Classification & Regulation

This clearance is catalogued under FDA product code LFD , within the Unknown review panel as a device.