510(k) · Cleared
ClearedOral-B Dry Mouth Oral Rinse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Procter & Gamble Company · LFD Saliva, Artificial
Cleared on Sep 2, 2020 as substantially equivalent to K181134 (Sunstar Americas, Inc., 2018) after a 112-day review. Its family tree reaches back 2 generations to 2013. 1 later device descends from it.
- Decided
- Sep 2, 2020
- Review
- 112 days
- Class
- Class U
- Product code
- LFD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K123731 (2013). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK123731 Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene…Glaxosmithkline Consumer Healthcare (Gskch) · 2013 · Recalled
- 1 generation backK181134 G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse…Sunstar Americas, Inc. · 2018 · Recalled
- This deviceK201277 Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company · 2020
- Descendant · cites it directly · 0 of its ownK203567 Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company · 2021
Most influential descendants
Showing 1 of 1 · See all- K203567Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K123731 | Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing… | Glaxosmithkline Consumer Healthcare (Gskch) | 2013 | 1 |
| −1 | 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 |
| 0 (this device) | K201277 | Oral-B Dry Mouth Oral Rinse | The Procter & Gamble Company | 2020 | — |
| +1 | K203567 | Oral-B Dry Mouth Oral Rinse | The Procter & Gamble Company | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K181134 | G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry…Summary page 5…ified Device Classification: Unclassified GMP exempt: No Review Panel: Dental PREDICATE / REFFERENCE DEVICE GUM® HYDRAL™ Dry Mouth Oral Rinse (K181134) To the best of our knowledge the predicate device has not been the subject of any design-related recalls. Oral-B® Dry Mout… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203567 | Oral-B Dry Mouth Oral Rinse | 2021 | 0 |
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 7 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K203567 (The Procter & Gamble Company, 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LFD devicesLFD Saliva, Artificial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LFD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFD
287in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFD
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFD
11in 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 4 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201277: Oral-B Dry Mouth Oral Rinse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201277
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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