Cleared Traditional

K203567 - Oral-B Dry Mouth Oral Rinse (FDA 510(k) Clearance)

K203567 · The Procter & Gamble Company · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
119d
Days
-
Risk

K203567 is an FDA 510(k) clearance for the Oral-B Dry Mouth Oral Rinse. Classified as Saliva, Artificial (product code LFD).

Submitted by The Procter & Gamble Company (Cincinnati, US). The FDA issued a Cleared decision on April 5, 2021 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all The Procter & Gamble Company devices

Submission Details

510(k) Number K203567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2020
Decision Date April 05, 2021
Days to Decision 119 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 127d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Clinical Evidence

ClinicalTrials.gov
NCT04189081 Completed Interventional Industry-sponsored

Improvement of Dry Mouth Sufferers After Using an Experimental Dry Mouth Rinse Compared to a Water Control

A Clinical Study to Evaluate Dry Mouth Relief After Using an Experimental Mouth Rinse Compared to a Water Control

137
Patients (actual)
1
Site
Treatment
Purpose
Double blind
Masking
Condition studied Dry Mouth
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Jeff Milleman, DDS
Sponsor Procter and Gamble (industry)
Started 2020-05-13 → Primary completion 2020-07-08
Primary outcome
Response to "Relieving the Discomfort of Dry Mouth" From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment
View full study on ClinicalTrials.gov

Regulatory Peers - LFD Saliva, Artificial

All 49
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K203567.
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