510(k) · Cleared
ClearedOral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA · LFD Saliva, Artificial
Cleared on May 26, 2015 as substantially equivalent to K061331 (Laclede, Inc., 2006) and 1 other predicate after a 258-day review. Its family tree reaches back 6 generations to 1988. 1 later device descends from it.
- Decided
- May 26, 2015
- Review
- 258 days
- Class
- Class U
- Product code
- LFD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K874106 (1988). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK874106 Glandosane (Salivart) Synthetic SalivaFresenius USA, Inc. · 1988
- 5 generations backK991938 Caphosol Artificial SalivaInpharma A.S. · 1999
- 4 generations backK024148 Salinum, OrclairSinclair Pharmaceuticals, Ltd. · 2003
- 3 generations backK051812 Tgo SprayLaboratoires Carilene S.A.S. · 2005
- 2 generations backK061331 Oral Balance Liquid/ GelLaclede, Inc. · 2006
- 1 generation backK101477 Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth MouthwashGlaxosmithkline Consumer Healthcare (Gskch) · 2010
- This deviceK142549 Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7…J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA · 2015
- Descendant · cites it directly · 0 of its ownK240508 Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240508Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K874106 | Glandosane (Salivart) Synthetic Saliva | Fresenius USA, Inc. | 1988 | — |
| −5 | K991938 | Caphosol Artificial Saliva | Inpharma A.S. | 1999 | — |
| −4 | K024148 | Salinum, Orclair | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| −3 | K051812 | Tgo Spray | Laboratoires Carilene S.A.S. | 2005 | — |
| −2 | K061331 | Oral Balance Liquid/ Gel | Laclede, Inc. | 2006 | — |
| −1 | K101477 | Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth Mouthwash | Glaxosmithkline Consumer Healthcare (Gskch) | 2010 | — |
| 0 (this device) | K142549 | Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth… | J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA | 2015 | — |
| +1 | K240508 | Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) | Laclede, Inc. | 2024 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K061331 | Oral Balance Liquid/ GelSummary page 5…C.E.C. Company, Inc. Oral7™ 510(k) Section 5 5.3. Equivalent Device Identification The primary predicate device for Oral7™ Moisturizing Gel is Oral Balance Gel (K061331); the primary predicate device for Oral7™ Moisturizing Mouthwash and Oral7™ Moisturizing Mouth Spray is Biotène® Dry Mouth Oral R… | 2006 |
| * | K101477 | Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth MouthwashSummary page 5…g Gel is Oral Balance Gel (K061331); the primary predicate device for Oral7™ Moisturizing Mouthwash and Oral7™ Moisturizing Mouth Spray is Biotène® Dry Mouth Oral Rinse (K101477). The formulation of Oral7™ Moisturizing Mouthwash is identical to the formulation of Oral7™ Moisturizing Mouth Spray. The produc… | 2010 |
| † | K103745 | Biotene Moisturizing Mouth Spray for Dry Mouth Symptom Relief | 2011 |
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 |
|---|---|---|---|
| K240508 | Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) | 2024 | 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 27 years and passes through 7 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K240508 (Laclede, Inc., 2024) has gone furthest, with 0 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. 2015, 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?
Relieve symptoms of dry mouth, refresh, moisturize, clean and soothe oral irritation, and lubricate oral dryness.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142549: Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142549
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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