510(k) · Cleared
ClearedBiotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth Mouthwash
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Glaxosmithkline Consumer Healthcare (Gskch) · LFD Saliva, Artificial
Cleared on Sep 28, 2010 as substantially equivalent to K061331 (Laclede, Inc., 2006) after a 123-day review. Its family tree reaches back 5 generations to 1988. 6 later devices descend from it.
- Decided
- Sep 28, 2010
- Review
- 123 days
- Class
- Class U
- Product code
- LFD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K874106 (1988). 7 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK874106 Glandosane (Salivart) Synthetic SalivaFresenius USA, Inc. · 1988
- 4 generations backK991938 Caphosol Artificial SalivaInpharma A.S. · 1999
- 3 generations backK024148 Salinum, OrclairSinclair Pharmaceuticals, Ltd. · 2003
- 2 generations backK051812 Tgo SprayLaboratoires Carilene S.A.S. · 2005
- 1 generation backK061331 Oral Balance Liquid/ GelLaclede, Inc. · 2006
- This deviceK101477 Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth MouthwashGlaxosmithkline Consumer Healthcare (Gskch) · 2010
- Descendant · cites it directly · 2 of its ownK111250 Dry Mouth MouthwashDr. Fresh, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK180680 Salivea Dry Mouth Mouthwash, Salivea Dry Mouth MouthsprayLaclede, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK142549 Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7…J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA · 2015
- Descendant · 2 generations on · 0 of its ownK240508 Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK173237 Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free…Syendgen, Inc. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K111250Dry Mouth MouthwashDr. Fresh, Inc. · 2012 · cites it directly2descendants
- K180680Salivea Dry Mouth Mouthwash, Salivea Dry Mouth MouthsprayLaclede, Inc. · 2018 · cites it directly1descendant
- K142549Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray…J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA · 2015 · cites it directly1descendant
- K240508Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc. · 2024 · 2 generations on0descendants
- K173237Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral…Syendgen, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K874106 | Glandosane (Salivart) Synthetic Saliva | Fresenius USA, Inc. | 1988 | — |
| −4 | K991938 | Caphosol Artificial Saliva | Inpharma A.S. | 1999 | — |
| −3 | K024148 | Salinum, Orclair | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| −2 | K051812 | Tgo Spray | Laboratoires Carilene S.A.S. | 2005 | — |
| −1 | K061331 | Oral Balance Liquid/ Gel | Laclede, Inc. | 2006 | — |
| 0 (this device) | K101477 | Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth Mouthwash | Glaxosmithkline Consumer Healthcare (Gskch) | 2010 | — |
| +1 | K111250 | Dry Mouth Mouthwash | Dr. Fresh, Inc. | 2012 | — |
| +1 | K180680 | Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray | Laclede, Inc. | 2018 | — |
| +1 | K142549 | Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth… | J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA | 2015 | — |
| +2 | K240508 | Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) | Laclede, Inc. | 2024 | — |
| +2 | K173237 | Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth… | Syendgen, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 3 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K061331 | Oral Balance Liquid/ GelSummary page 1…ion Name (if known): Saliva, Artificial 3. IDENTIFICATION OF EQUIVALENCE Laclede, Inc. Oral Balance Gel cleared in K061331I Laclede, Inc. OralBalance Liquid cleared in K061331 4. DEVICE DESCRIPTION Biot&ne Dry M… | 2006 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K111250 (Dr. Fresh, Inc., 2012) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K061331.
How does its category compare?
All LFD devicesLFD Saliva, Artificial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation, and lubricates oral dryness.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101477: Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth Mouthwash.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101477
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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