510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray

K123731510(k) SpecialCleared Jan 4, 201330-day reviewClass URecalls 1

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

Glaxosmithkline Consumer Healthcare (Gskch) · LFD Saliva, Artificial

Cleared on Jan 4, 2013 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 14 later devices descend from it. It has been recalled once.

Decided
Jan 4, 2013
Review
30 days
Class
Class U
Product code
LFD
Recalls
1
Predicates
0

14 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2015: 2 descendants cleared2018: 2 descendants cleared2019: 3 descendants cleared2025: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared2020: 1 descendant cleared2021: 1 descendant cleared2010201520202025
  1. This deviceK123731 Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene…Glaxosmithkline Consumer Healthcare (Gskch) · 2013
  2. Descendant · cites it directly · 2 of its ownK181134 G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse…Sunstar Americas, Inc. · 2018 · Recalled
  3. Descendant · cites it directly · 2 of its ownK163029 Hydris™ Oral RinseBiopharm Consult, LLC · 2017
  4. Descendant · 2 generations on · 1 of its ownK201277 Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company · 2020
  5. Descendant · cites it directly · 1 of its ownK152201 MedActive Oral Gel and SprayMedactive Oral Pharmaceuticals, LLC · 2015
  6. Descendant · cites it directly · 1 of its ownK150074 Elevate Moisturizing SprayElevate Oral Care · 2015

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2015: 22017: 12018: 22019: 32020: 12021: 12023: 12024: 12025: 12026: 1
2015high 3 (2019) · low 0 (2016)2026

Most influential descendants

Showing 5 of 14 · See all
  • K181134G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry…Sunstar Americas, Inc. · 2018 · cites it directly2descendants
  • K163029Hydris™ Oral RinseBiopharm Consult, LLC · 2017 · cites it directly2descendants
  • K201277Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company · 2020 · 2 generations on1descendant
  • K152201MedActive Oral Gel and SprayMedactive Oral Pharmaceuticals, LLC · 2015 · cites it directly1descendant
  • K150074Elevate Moisturizing SprayElevate Oral Care · 2015 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K123731Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing…Glaxosmithkline Consumer Healthcare (Gskch)2013—
+1K181134G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M…Sunstar Americas, Inc.20181
+1K163029Hydris™ Oral RinseBiopharm Consult, LLC2017—
+2K201277Oral-B Dry Mouth Oral RinseThe Procter & Gamble Company2020—
+1K152201MedActive Oral Gel and SprayMedactive Oral Pharmaceuticals, LLC2015—
+1K150074Elevate Moisturizing SprayElevate Oral Care2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201710
201820
201930
202010
202110
202310
202410
202510
202610
FIG. 1 — Lineage of K123731, 2013–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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. #1 K253778 Allday Moisturizing Rinsescore 11.2 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (14)

See all 14

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K181134G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry…Sunstar Americas, Inc.20182
K163029Hydris™ Oral RinseBiopharm Consult, LLC20172
K152201MedActive Oral Gel and SprayMedactive Oral Pharmaceuticals, LLC20151
K150074Elevate Moisturizing SprayElevate Oral Care20151
K250390CloSYS® Dry Mouth Sensitive Mouth RinseRowpar Pharmaceuticals, Inc.20250
K240508Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc.20240
K231205GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayGurunanda, LLC20230
K181839CVS Health Dry Mouth Spray, OraLabs Dry Mouth SprayOralabs, Inc.20190
K181194SmartMouth DryMouth Oral RinseTriumph Pharmaceuticals, Inc.20190

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 17, 2013Class IIZ-0272-2014Labeling Change ControlLabel indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K181134 (Sunstar Americas, Inc., 2018) has gone furthest, with 2 descendants of its own.

How does its category compare?

All LFD devices

LFD Saliva, Artificial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · LFD

1in 2025

2007: 22009: 32010: 12011: 32012: 22013: 22015: 52017: 32018: 52019: 32020: 12021: 22023: 12024: 22025: 12026 (partial year): 1
2007high 5 (2015) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LFD

287in 2019

2009: 83 days median2011: 209 days median2015: 156 days median2017: 231 days median2018: 210 days median2019: 287 days median
2007high 287 (2019) · low 83 (2009)2026

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

Recalls per year · LFD

1in 2013

2007: 12013: 1
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

2007: 22010: 12011: 52012: 72013: 372014: 192015: 282016: 682017: 512018: 372019: 402020: 342021: 302022: 152023: 102024: 142025: 11
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—12
20080—00
200938300
20101—01
2011320905
20122—07
20132—137
20140—019
20155156028
20160—068
20173231051
20185210037
20193287040
20201—034
20212—030
20220—015
20231—010
20242—014
20251—011
20261—0—

What is it indicated for?

The biotene Oral Balance Gel, biotene Dry Mouth Oral Rinse and biotene Moisturizing Mouth Spray intended use is to relieve the symptoms of day mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.

Indications for use as stated in the FDA 510(k) statement.

More from Glaxosmithkline Consumer Healthcare…

3 FDA decisions under this applicant name. See the company

  • K103745Biotene Moisturizing Mouth Spray for Dry Mouth Symptom ReliefGlaxosmithkline Consumer Healthcare (Gskch) · 2011
  • K101477Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth MouthwashGlaxosmithkline Consumer Healthcare (Gskch) · 2010

Recent decisions in LFD

The LFD category page

  • K253778Allday Moisturizing RinseElevate Oral Care · 2026
  • K250390CloSYS® Dry Mouth Sensitive Mouth RinseRowpar Pharmaceuticals, Inc. · 2025
  • K240508Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc. · 2024
  • K234015Caphosol® Artifical Saliva (32 doses sachet box)Eusa Pharma (Uk) Limited · 20241 recall
  • K231205GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayGurunanda, LLC · 2023

https://510kreport.com/device/K123731 · printed Nov 3, 2026

Cite this page

510(k) Report. “K123731: Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123731

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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