510(k) · Cleared
ClearedSilatrix Oral Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sa3, LLC · OLR Oral Wound Dressing
Cleared on Oct 23, 2025 as substantially equivalent to K202000 (Sa3, LLC, 2020) after an 83-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Oct 23, 2025
- Review
- 83 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K953423 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK953423 Casrrasyn Oral Wound DressingCarrington Laboratories, Inc. · 1995
- 5 generations backK012126 The Salicept Oral PatchCarrington Laboratories, Inc. · 2001
- 4 generations backK043587 Sucralfate and Carafate Paste KitsPatrick D. Mcgrath Ph.D · 2006
- 3 generations backK082856 Carapaste Oral Wound DressingMcgrath Pharmaceuticals, Inc. · 2008
- 2 generations backK123904 ProthelialMueller Medical International, LLC · 2013
- 1 generation backK202000 Silatrix Oral GelSa3, LLC · 2020 · Recalled
- This deviceK252425 Silatrix Oral GelSa3, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K953423 | Casrrasyn Oral Wound Dressing | Carrington Laboratories, Inc. | 1995 | — |
| −5 | K012126 | The Salicept Oral Patch | Carrington Laboratories, Inc. | 2001 | — |
| −4 | K043587 | Sucralfate and Carafate Paste Kits | Patrick D. Mcgrath Ph.D | 2006 | — |
| −3 | K082856 | Carapaste Oral Wound Dressing | Mcgrath Pharmaceuticals, Inc. | 2008 | — |
| −2 | K123904 | Prothelial | Mueller Medical International, LLC | 2013 | — |
| −1 | K202000 | Silatrix Oral Gel | Sa3, LLC | 2020 | 1 |
| 0 (this device) | K252425 | Silatrix Oral Gel | Sa3, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 OLR? 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 OLR device
- #1 K253758 Dental Cone; Dental Spongescore 13.2 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K202000 | Silatrix Oral GelSummary page 5…Name Oral Wound Dressing Classification Information Class: Unclassified Product Code: OLR Product Code Description: Oral Wound Dressing Predicate Device 510(k) Number: K202000 Trade/Proprietary/Model Name: Silatrix Oral Gel Common/Usual Name: Oral Wound Dressing Product Code: OLR, FRO Class: Unclassified… | 2020 |
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 30 years and passes through 5 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All OLR devicesOLR Oral Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OLR
4so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · OLR
83in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLR
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OLR
5in 2025
MAUDE reports naming product code OLR, 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 | 3 | 93 | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 3 | 115 | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 2 | — | 1 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 83 | 0 | 5 |
| 2026 | 4 | 188 | 0 | — |
What is it indicated for?
Silatrix Oral Gel forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The oral gel may be used in the management of mouth lesions including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill-fitting dentures, and lesions associated with oral surgery.
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/K252425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252425: Silatrix Oral Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252425
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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