510(k) · Cleared

Cleared

Oral-B Dry Mouth Oral Rinse

K203567510(k) TraditionalCleared Apr 5, 2021119-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

The Procter & Gamble Company · LFD Saliva, Artificial

Cleared on Apr 5, 2021 as substantially equivalent to K201277 (The Procter & Gamble Company, 2020) after a 119-day review. Its family tree reaches back 3 generations to 2013.

Decided: Apr 5, 2021
Review: 119 days
Class: Class U
Product code: LFD
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K123731 (2013). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK123731 Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene…Glaxosmithkline Consumer Healthcare (Gskch) · 2013 · Recalled
2 generations backK181134 G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse…Sunstar Americas, Inc. · 2018 · Recalled
1 generation backK201277 Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company · 2020
This deviceK203567 Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company · 2021

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K123731	Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing…	Glaxosmithkline Consumer Healthcare (Gskch)	2013	1
−2	K181134	G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M…	Sunstar Americas, Inc.	2018	1
−1	K201277	Oral-B Dry Mouth Oral Rinse	The Procter & Gamble Company	2020	—
0 (this device)	K203567	Oral-B Dry Mouth Oral Rinse	The Procter & Gamble Company	2021	—

FIG. 1 — Lineage of K203567, 2013–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LFD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LFD device

#1 K253778 Allday Moisturizing Rinsescore 11.2 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K201277	Oral-B Dry Mouth Oral Rinse Summary page 4 …ed Device Classification: Unclassified GMP exempt: No Review Panel: Dental PREDICATE / REFFERENCE DEVICE Oral-B® Dry Mouth Oral Rinse (K201277) The predicate device has not been the subject of any design-related recalls. Oral-B® Dry Mouth Oral Rinse K203567…	The Procter & Gamble Company	2020	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
2 of the 3 ancestors have a recall of any class.

How does its category compare?

All LFD devices

LFD Saliva, Artificial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · LFD

1in 2025

2007high 5 (2015) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LFD

287in 2019

2007high 287 (2019) · low 83 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LFD

1in 2013

2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LFD

11in 2025

2007high 68 (2016) · low 0 (2008)2025

MAUDE reports naming product code LFD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	1	2
2008	0	—	0	0
2009	3	83	0	0
2010	1	—	0	1
2011	3	209	0	5
2012	2	—	0	7
2013	2	—	1	37
2014	0	—	0	19
2015	5	156	0	28
2016	0	—	0	68
2017	3	231	0	51
2018	5	210	0	37
2019	3	287	0	40
2020	1	—	0	34
2021	2	—	0	30
2022	0	—	0	15
2023	1	—	0	10
2024	2	—	0	14
2025	1	—	0	11
2026	1	—	0	—

What is it indicated for?

Relieves the symptoms and discomfort of dry mouth, refreshes, moisturizes/hydrates, soothes oral irritation and lubricates oral dryness.

Provides long lasting relief for up to 6 hours.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K203567 · printed Nov 5, 2026

Cite this page

510(k) Report. “K203567: Oral-B Dry Mouth Oral Rinse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203567

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026