Cleared Traditional

Oral-B Dry Mouth Oral Rinse (K201277) - FDA 510(k) Clearance

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

K201277 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 September 2, 2020 after a review of 112 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 K201277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 127d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 16
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K201277.
GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
K231205 · Gurunanda, LLC · Aug 2023
Dentilube Spray
K202689 · Oxy2plus, LLC · Sep 2021
Oral-B Dry Mouth Oral Rinse
K203567 · The Procter & Gamble Company · Apr 2021
CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray
K181839 · Oralabs, Inc. · Nov 2019
MucoPEG
K190144 · Sunbio, Inc. · Nov 2019
SmartMouth DryMouth Oral Rinse
K181194 · Triumph Pharmaceuticals, Inc. · Feb 2019