510(k) · Cleared
ClearedGC Oral Moisturizing Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GC America, Inc. · LFD Saliva, Artificial
Cleared on Jan 27, 2011 as substantially equivalent to K072306 (Bio-X Healthcare S.A., 2007) and 1 other predicate after a 259-day review. Its family tree reaches back 7 generations to 1988.
- Decided
- Jan 27, 2011
- Review
- 259 days
- Class
- Class U
- Product code
- LFD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K874106 (1988). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK874106 Glandosane (Salivart) Synthetic SalivaFresenius USA, Inc. · 1988
- 6 generations backK991938 Caphosol Artificial SalivaInpharma A.S. · 1999
- 5 generations backK024148 Salinum, OrclairSinclair Pharmaceuticals, Ltd. · 2003
- 4 generations backK051812 Tgo SprayLaboratoires Carilene S.A.S. · 2005
- 3 generations backK061331 Oral Balance Liquid/ GelLaclede, Inc. · 2006
- 2 generations backK062653 Mouthkote Oral Moisturizer, Model 50930-098Parnell Pharmaceuticals, Inc. · 2006
- 1 generation backK072306 Bioxtra Moisturizing GelBio-X Healthcare S.A. · 2007
- This deviceK101346 GC Oral Moisturizing GelGC America, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K874106 | Glandosane (Salivart) Synthetic Saliva | Fresenius USA, Inc. | 1988 | — |
| −6 | K991938 | Caphosol Artificial Saliva | Inpharma A.S. | 1999 | — |
| −5 | K024148 | Salinum, Orclair | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| −4 | K051812 | Tgo Spray | Laboratoires Carilene S.A.S. | 2005 | — |
| −3 | K061331 | Oral Balance Liquid/ Gel | Laclede, Inc. | 2006 | — |
| −2 | K062653 | Mouthkote Oral Moisturizer, Model 50930-098 | Parnell Pharmaceuticals, Inc. | 2006 | — |
| −1 | K072306 | Bioxtra Moisturizing Gel | Bio-X Healthcare S.A. | 2007 | — |
| 0 (this device) | K101346 | GC Oral Moisturizing Gel | GC America, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 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? (2)
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 |
|---|---|---|---|
| * | K072306 | Bioxtra Moisturizing GelSummary page 1…Predicate Devices: Icompany IDevice IK Number BioXtra Moisturii GeCi- Healthcare S.A. K072306 Oral Balance Li( ulGl Lae, inc. K061331 4. Descrtion of Device: GIC Oral Moistur… | 2007 |
| * | K061331 | Oral Balance Liquid/ GelSummary page 1…IK Number BioXtra Moisturii GeCi- Healthcare S.A. K072306 Oral Balance Li( ulGl Lae, inc. K061331 4. Descrtion of Device: GIC Oral Moisturizing Gel contains polyglycerol (diglycerol) which, with other ingredients… | 2006 |
| † | K070854 | GC MI Paste Plus | 2007 |
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 23 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 1 other device also cites its predicate K072306.
How does its category compare?
All LFD devicesLFD Saliva, Artificial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
GC Oral Moisturizing Gel is designed to provide comfort for individuals suffering from dry mouth. It is recommended to be used for people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry mouth.
GC Oral Moisturizing Gel is indicated for the relief of dry mouth symptoms, to provide a protective coating inside the mouth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101346: GC Oral Moisturizing Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101346
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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