510(k) · Cleared
ClearedThe Salicept Oral Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carrington Laboratories, Inc. · OLR Oral Wound Dressing
Cleared on Oct 3, 2001 as substantially equivalent to K953423 (Carrington Laboratories, Inc., 1995) after an 89-day review. Its family tree reaches back 1 generation to 1995. 17 later devices descend from it.
- Decided
- Oct 3, 2001
- Review
- 89 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953423 (1995). 17 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK953423 Casrrasyn Oral Wound DressingCarrington Laboratories, Inc. · 1995
- This deviceK012126 The Salicept Oral PatchCarrington Laboratories, Inc. · 2001
- Descendant · cites it directly · 8 of its ownK063148 Sock IT! Oral Pain GelMerlin Group Dba Mcmerlin Dental Company · 2007
- Descendant · 2 generations on · 4 of its ownK210211 PuraStat-OM3-D Matrix, Inc. · 2021
- Descendant · cites it directly · 4 of its ownK043587 Sucralfate and Carafate Paste KitsPatrick D. Mcgrath Ph.D · 2006
- Descendant · 3 generations on · 3 of its ownK213552 PuraStat-RM3-D Matrix, Inc. · 2022
- Descendant · 2 generations on · 3 of its ownK082856 Carapaste Oral Wound DressingMcgrath Pharmaceuticals, Inc. · 2008
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K063148Sock IT! Oral Pain GelMerlin Group Dba Mcmerlin Dental Company · 2007 · cites it directly8descendants
- K210211PuraStat-OM3-D Matrix, Inc. · 2021 · 2 generations on4descendants
- K043587Sucralfate and Carafate Paste KitsPatrick D. Mcgrath Ph.D · 2006 · cites it directly4descendants
- K213552PuraStat-RM3-D Matrix, Inc. · 2022 · 3 generations on3descendants
- K082856Carapaste Oral Wound DressingMcgrath Pharmaceuticals, Inc. · 2008 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953423 | Casrrasyn Oral Wound Dressing | Carrington Laboratories, Inc. | 1995 | — |
| 0 (this device) | K012126 | The Salicept Oral Patch | Carrington Laboratories, Inc. | 2001 | — |
| +1 | K063148 | Sock IT! Oral Pain Gel | Merlin Group Dba Mcmerlin Dental Company | 2007 | — |
| +2 | K210211 | PuraStat-OM | 3-D Matrix, Inc. | 2021 | — |
| +1 | K043587 | Sucralfate and Carafate Paste Kits | Patrick D. Mcgrath Ph.D | 2006 | — |
| +3 | K213552 | PuraStat-RM | 3-D Matrix, Inc. | 2022 | — |
| +2 | K082856 | Carapaste Oral Wound Dressing | Mcgrath Pharmaceuticals, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K953423 | Casrrasyn Oral Wound DressingSummary page 5…25446 DATE OF SUMMARY: June 19, 2001 CLASSIFICATION OF THE DEVICE: Unclassified under 21 CFR 8728.4022, hydrogel wound dressing and burn dressing. The predicate device, K953423, The Carrington™ Patch, is an unclassified device. DEVICE DESCRIPTION: The SaliCept Oral Patch is a freeze-dried gel that conta… | 1995 |
What descends from it? (17)
See all 173 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?
How does its category compare?
All OLR devicesOLR Oral Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Recommended for use in tooth extraction sites and management of alveolar osteitis (dry socket). The SaliCept Oral Patch is also intended for the management of all types of oral wounds, injuries and ulcers of the oral mucosa. The Salicept Oral Patch relieves pain by adhering to and protecting affected tissues from further irritation.
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/K012126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012126: The Salicept Oral Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012126
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026