Cleared Traditional

Oral-B Dry Mouth Oral Rinse

K201277 · The Procter & Gamble Company · Dental
Sep 2020
Decision
112d
Days
—
Risk

About This 510(k) Submission

K201277 is an FDA 510(k) clearance for the Oral-B Dry Mouth Oral Rinse, a Saliva, Artificial, submitted by The Procter & Gamble Company (Cincinnati, US). The FDA issued a Cleared decision on September 2, 2020, 112 days after receiving the submission on May 13, 2020. This device falls under the Dental review panel.

Submission Details

510(k) Number K201277 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2020
Decision Date September 02, 2020
Days to Decision 112 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LFD — Saliva, Artificial
Device Class —

Similar Devices — LFD Saliva, Artificial

All 49
Allday Moisturizing Rinse
K253778 · Elevate Oral Care · Feb 2026
CloSYS? Dry Mouth Sensitive Mouth Rinse
K250390 · Rowpar Pharmaceuticals, Inc. · May 2025
Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
K240508 · Laclede, Inc. · Apr 2024
Caphosol? Artifical Saliva (32 doses sachet box)
K234015 · Eusa Pharma (Uk) Limited · Mar 2024
GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
K231205 · Gurunanda, LLC · Aug 2023
Dentilube Spray
K202689 · Oxy2plus, LLC · Sep 2021