510(k) · Cleared
Recalled · Class II · 2022Silatrix 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 Nov 20, 2020 as substantially equivalent to K123904 (Mueller Medical International, LLC, 2013) after a 123-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 20, 2020
- Review
- 123 days
- Class
- Class U
- Product code
- OLR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K953423 (1995). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK953423 Casrrasyn Oral Wound DressingCarrington Laboratories, Inc. · 1995
- 4 generations backK012126 The Salicept Oral PatchCarrington Laboratories, Inc. · 2001
- 3 generations backK043587 Sucralfate and Carafate Paste KitsPatrick D. Mcgrath Ph.D · 2006
- 2 generations backK082856 Carapaste Oral Wound DressingMcgrath Pharmaceuticals, Inc. · 2008
- 1 generation backK123904 ProthelialMueller Medical International, LLC · 2013
- This deviceK202000 Silatrix Oral GelSa3, LLC · 2020
- Descendant · cites it directly · 0 of its ownK252425 Silatrix Oral GelSa3, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K252425Silatrix Oral GelSa3, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953423 | Casrrasyn Oral Wound Dressing | Carrington Laboratories, Inc. | 1995 | — |
| −4 | K012126 | The Salicept Oral Patch | Carrington Laboratories, Inc. | 2001 | — |
| −3 | K043587 | Sucralfate and Carafate Paste Kits | Patrick D. Mcgrath Ph.D | 2006 | — |
| −2 | K082856 | Carapaste Oral Wound Dressing | Mcgrath Pharmaceuticals, Inc. | 2008 | — |
| −1 | K123904 | Prothelial | Mueller Medical International, LLC | 2013 | — |
| 0 (this device) | K202000 | Silatrix Oral Gel | Sa3, LLC | 2020 | — |
| +1 | K252425 | Silatrix Oral Gel | Sa3, LLC | 2025 | — |
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 |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K123904 | ProthelialSummary page 4…cross-linked sucralfate gel treatment Classification Name Product Code: OLR, FRO Unclassified Oral Wound Dressing, Dressing, Wound, Drug Primary Predicate K-Number: K123904 Common or Usual Name: Sucralfate Malate Paste Trade/Proprietary/Model Name: ProThelial & Orafate Sucralfate Paste Classification… | 2013 |
| † | K193336 | Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse | 2020 |
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 |
|---|---|---|---|
| K252425 | Silatrix Oral Gel | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 21, 2022 | Class II | Z-0856-2022 | Under Investigation by firm | Due to failure of microbial testing for total aerobic microbial count (TAMC). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K252425 (Sa3, LLC, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OLR devicesOLR Oral Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 as stated in the FDA summary.
https://510kreport.com/device/K202000 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202000: 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/K202000
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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