510(k) · Cleared
ClearedBioxtra Moisturizing Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-X Healthcare S.A. · LFD Saliva, Artificial
Cleared on Nov 15, 2007 as substantially equivalent to K062653 (Parnell Pharmaceuticals, Inc., 2006) and 4 other predicates after a 90-day review. Its family tree reaches back 6 generations to 1988. 2 later devices descend from it.
- Decided
- Nov 15, 2007
- Review
- 90 days
- Class
- Class U
- Product code
- LFD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K874106 (1988). 8 ancestors in all. 2 later devices descend from it, 2 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 backK062653 Mouthkote Oral Moisturizer, Model 50930-098Parnell Pharmaceuticals, Inc. · 2006
- This deviceK072306 Bioxtra Moisturizing GelBio-X Healthcare S.A. · 2007
- Descendant · cites it directly · 0 of its ownK202689 Dentilube SprayOxy2plus, LLC · 2021
- Descendant · cites it directly · 0 of its ownK101346 GC Oral Moisturizing GelGC America, Inc. · 2011
Most influential descendants
Showing 2 of 2 · See allView 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 | K062653 | Mouthkote Oral Moisturizer, Model 50930-098 | Parnell Pharmaceuticals, Inc. | 2006 | — |
| 0 (this device) | K072306 | Bioxtra Moisturizing Gel | Bio-X Healthcare S.A. | 2007 | — |
| +1 | K202689 | Dentilube Spray | Oxy2plus, LLC | 2021 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K062653 | Mouthkote Oral Moisturizer, Model 50930-098Summary page 1…Panel: Dental D. Devices to Which New Device is Substantially Equivalent: Parnell Pharmaceuticals Inc. Mouthkote Oral Moisturizer, cleared K062653 Laclede Inc. Oralbalance Gel and Liquid, cleared in K061331 Gebauer Company: Salivart Spray… | 2006 |
| * | K061331 | Oral Balance Liquid/ GelSummary page 1…tially Equivalent: Parnell Pharmaceuticals Inc. Mouthkote Oral Moisturizer, cleared K062653 Laclede Inc. Oralbalance Gel and Liquid, cleared in K061331 Gebauer Company: Salivart Spray, cleared in K981693 Inpharma AB: Caphasol cleared in K03080… | 2006 |
| * | K981693 | Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model…Summary page 1…oisturizer, cleared K062653 Laclede Inc. Oralbalance Gel and Liquid, cleared in K061331 Gebauer Company: Salivart Spray, cleared in K981693 Inpharma AB: Caphasol cleared in K030802 Sinclair Pharmaceuticals Salinum or Oraclair, cleared in K… | 2001 |
| * | K030802 | CaphosolSummary page 1…Oralbalance Gel and Liquid, cleared in K061331 Gebauer Company: Salivart Spray, cleared in K981693 Inpharma AB: Caphasol cleared in K030802 Sinclair Pharmaceuticals Salinum or Oraclair, cleared in K024148 E. Device Description:… | 2003 |
| * | K024148 | Salinum, OrclairSummary page 1…Salivart Spray, cleared in K981693 Inpharma AB: Caphasol cleared in K030802 Sinclair Pharmaceuticals Salinum or Oraclair, cleared in K024148 E. Device Description: BioXtra® Moisturizing Gel contains a patented formulation… | 2003 |
What descends from it? (2)
2 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 19 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K202689 (Oxy2plus, LLC, 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. 2007, 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?
Under the supervision of a healthcare professional, BioXtra® Moisturizing Gel is indicated for relief from chronic and temporary xerostomia (dry mouth), which may be a result of disease such as Sj6gren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stress or aging. Relieves symptoms of dry mouth such as difficulties in swallowing, speech, and changes in taste and replaces missing saliva feel.
BioXtra® Moisturizing Gel is indicated for the symptomatic relief from the effects of chronic or temporary xerostomia (dry mouth), mouth discomfort, mouth odors and other oral symptoms associated with dry mouth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072306: Bioxtra 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/K072306
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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