510(k) · Cleared
ClearedSST Saliva Supporting Tablets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sinclair Pharmaceuticals, Ltd. · LED Stains, Chemical Solution
Cleared on Dec 2, 2002 as substantially equivalent to K981693 (Gebauer Co., 2001) and 1 other predicate after an 81-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- Dec 2, 2002
- Review
- 81 days
- Class
- Class I
- Product code
- LED
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K874106 (1988). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK874106 Glandosane (Salivart) Synthetic SalivaFresenius USA, Inc. · 1988
- 1 generation backK991938 Caphosol Artificial SalivaInpharma A.S. · 1999
- This deviceK023046 SST Saliva Supporting TabletsSinclair Pharmaceuticals, Ltd. · 2002
- Descendant · cites it directly · 0 of its ownK041563 Oasis Dry Mouth Relief Discs or Oasis Mouth Moisturizing DiscsGlaxosmithkline Consumer Healthcare, L.P. · 2004
Most influential descendants
Showing 1 of 1 · See all- K041563Oasis Dry Mouth Relief Discs or Oasis Mouth Moisturizing DiscsGlaxosmithkline Consumer Healthcare, L.P. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K874106 | Glandosane (Salivart) Synthetic Saliva | Fresenius USA, Inc. | 1988 | — |
| −1 | K991938 | Caphosol Artificial Saliva | Inpharma A.S. | 1999 | — |
| 0 (this device) | K023046 | SST Saliva Supporting Tablets | Sinclair Pharmaceuticals, Ltd. | 2002 | — |
| +1 | K041563 | Oasis Dry Mouth Relief Discs or Oasis Mouth Moisturizing Discs | Glaxosmithkline Consumer Healthcare, L.P. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 LED? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K981693 | Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model…Summary page 1…ssification Names: Dental: Saliva, artificial 3. Devices to Which New Device is Substantially Equivalent: Gebauer Company: Salivart cleared in 5 1O(k) K98 1693 and Inpharma AB: Caphosol cleared in 5 1O(k) K99 1938 4. Device Description: SST1” is formulated as a tablet that is allowed t… | 2001 |
| * | K991938 | Caphosol Artificial SalivaSummary page 1…ificial 3. Devices to Which New Device is Substantially Equivalent: Gebauer Company: Salivart cleared in 5 1O(k) K98 1693 and Inpharma AB: Caphosol cleared in 5 1O(k) K99 1938 4. Device Description: SST1” is formulated as a tablet that is allowed to dissolve slowly in the mouth. The tablets are presen… | 1999 |
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 |
|---|---|---|---|
| K041563 | Oasis Dry Mouth Relief Discs or Oasis Mouth Moisturizing Discs | 2004 | 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 14 years and passes through 3 companies; a new generation was cleared every 11.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K041563 (Glaxosmithkline Consumer Healthcare, L.P., 2004) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K981693.
How does its category compare?
All LED devicesLED Stains, Chemical Solution: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LED
FDA has decided no LED device since 2007.
Median 510(k) review, days · LED
Too few LED 510(k)s in any year since 2007 to give a median.
Recalls per year · LED
No recall names LED since 2007.
Adverse event reports per year · LED
5in 2025
MAUDE reports naming product code LED, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Under the supervision of a healthcare professional, SINCLAIR SSTTM promotes lubrication of oral mucosa that may be dry (xerostomia) due to, as may occur in a variety of circumstances including, medication, chemo or radiotherapy, Sjogren's Syndrome or oral inflammation. SINCLAIR SSTTM provides temporary relief for damaged salivary function.
Over the counter labeling stipulates that SINCLAIR SSTTM is suitable for temporary relief of dry mouth symptoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023046: SST Saliva Supporting Tablets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023046
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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