510(k) · Cleared
ClearedSock IT! Oral Pain Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merlin Group Dba Mcmerlin Dental Company · OLR Oral Wound Dressing
Cleared on Jan 17, 2007 as substantially equivalent to K933741 (Carrington Laboratories, Inc., 1994) and 4 other predicates after a 93-day review. Its family tree reaches back 2 generations to 1995. 8 later devices descend from it.
- Decided
- Jan 17, 2007
- Review
- 93 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K953423 (1995). 5 ancestors in all, the oldest K933741 (1994). 8 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK953423 Casrrasyn Oral Wound DressingCarrington Laboratories, Inc. · 1995
- 1 generation backK012126 The Salicept Oral PatchCarrington Laboratories, Inc. · 2001
- This deviceK063148 Sock IT! Oral Pain GelMerlin Group Dba Mcmerlin Dental Company · 2007
- Descendant · cites it directly · 4 of its ownK210211 PuraStat-OM3-D Matrix, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK213552 PuraStat-RM3-D Matrix, Inc. · 2022
- Descendant · 3 generations on · 2 of its ownK242634 PuraStat3-D Matrix Europe SAS · 2025
- Descendant · 4 generations on · 1 of its ownK253923 PuraStat3-D Matrix Europe SAS · 2026
- Descendant · cites it directly · 0 of its ownK260120 NaturaJel™ Oral Wound Care KitHCS Innovation, LLC · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K210211PuraStat-OM3-D Matrix, Inc. · 2021 · cites it directly4descendants
- K213552PuraStat-RM3-D Matrix, Inc. · 2022 · 2 generations on3descendants
- K242634PuraStat3-D Matrix Europe SAS · 2025 · 3 generations on2descendants
- K253923PuraStat3-D Matrix Europe SAS · 2026 · 4 generations on1descendant
- K260120NaturaJel™ Oral Wound Care KitHCS Innovation, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953423 | Casrrasyn Oral Wound Dressing | Carrington Laboratories, Inc. | 1995 | — |
| −1 | K012126 | The Salicept Oral Patch | Carrington Laboratories, Inc. | 2001 | — |
| 0 (this device) | K063148 | Sock IT! Oral Pain Gel | Merlin Group Dba Mcmerlin Dental Company | 2007 | — |
| +1 | K210211 | PuraStat-OM | 3-D Matrix, Inc. | 2021 | — |
| +2 | K213552 | PuraStat-RM | 3-D Matrix, Inc. | 2022 | — |
| +3 | K242634 | PuraStat | 3-D Matrix Europe SAS | 2025 | — |
| +4 | K253923 | PuraStat | 3-D Matrix Europe SAS | 2026 | — |
| +1 | K260120 | NaturaJel™ Oral Wound Care Kit | HCS Innovation, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K933741 | Carrasyn Oral Wound DressingSummary page 1…Trade name: "Sock It!" Oral Pain G: I Classification name: This device is unclassi: ed under 21UCFR Parts 862-892. PREDICATE DEVICES K933741 Carrasyn Oral Wound Dressing (m arketed as "OraPatchFM") K953423 Carrasyn Oral Wound Dressing (;narketed as "OraPatchiM a… | 1994 |
| * | K953423 | Casrrasyn Oral Wound DressingSummary page 1…ame: This device is unclassi: ed under 21UCFR Parts 862-892. PREDICATE DEVICES K933741 Carrasyn Oral Wound Dressing (m arketed as "OraPatchFM") K953423 Carrasyn Oral Wound Dressing (;narketed as "OraPatchiM and Ora3al r Mm") K964852 RadiaCare Oral Wound Rinse (marketed as… | 1995 |
| * | K964852 | Radiacare Oral Wound RinseSummary page 1…K933741 Carrasyn Oral Wound Dressing (m arketed as "OraPatchFM") K953423 Carrasyn Oral Wound Dressing (;narketed as "OraPatchiM and Ora3al r Mm") K964852 RadiaCare Oral Wound Rinse (marketed as "SaliCept T M Oral Stomatitis Rinse" ) K983 182 Caraloe Oral Ri… | 1997 |
| * | K983182 | Aloe Therapy Oral RinseSummary page 1…sing (;narketed as "OraPatchiM and Ora3al r Mm") K964852 RadiaCare Oral Wound Rinse (marketed as "SaliCept T M Oral Stomatitis Rinse" ) K983 182 Caraloe Oral Rinse (marketed as Carrington Oral Wound RinseIm") K012126 Salicept Oral Patch (marketed as SaiiCeptTM Freez… | 1998 |
| * | K012126 | The Salicept Oral PatchSummary page 1…ound Rinse (marketed as "SaliCept T M Oral Stomatitis Rinse" ) K983 182 Caraloe Oral Rinse (marketed as Carrington Oral Wound RinseIm") K012126 Salicept Oral Patch (marketed as SaiiCeptTM Freeze Dried Gel [FDG]) DEVICE DESCRIPTION "Sock It!" Oral Pain Gel is a clear, vis… | 2001 |
| † | K902345 | Carrington Wound Dressing | 1990 |
What descends from it? (8)
4 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 12 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K210211 (3-D Matrix, Inc., 2021) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K933741.
How does its category compare?
All OLR devicesOLR Oral Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
This product manages the pain in all types of oral wounds, mouth sores, injuries and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and further irritation and contamination, It provides the moist wound environment required for optimal wound healing. Manages pain of, for example: - All types of oral wounds, mouth sores, injuries and ulcers of the oral mucosa - Canker sores and cold sores - Irritation…
Read the full statement (232 words)
This product manages the pain in all types of oral wounds, mouth sores, injuries and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and further irritation and contamination, It provides the moist wound environment required for optimal wound healing.
Manages pain of, for example:
- All types of oral wounds, mouth sores, injuries and ulcers of the oral mucosa
- Canker sores and cold sores
- Irritation and traumatic ulcers such as those caused by various appliances such as braces, brackets, full and partial dentures and palatal expanders
- Soft tissue pain from orthodontics
- Aphthous ulcers
- Extraction site pain
- Oral mucositis and stomatitis
- Irritation and pain following tooth scaling and prophylaxis
This product manages the pain in all types of oral wounds, mouth sores, injuries and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and further irritation and contamination. It provides the moist wound environment required for optimal wound healing.
Manages pain of, for example:
- All types of oral wounds, mouth sores, injuries and ulcers of the mouth
- Canker sores and cold sores
- Irritation and traumatic ulcers such as those caused by various appliances such as braces, brackets, full and partial dentures and palatal expanders
- Aphthous ulcers
- Irritation and discomfort from ill-fitting dentures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063148: Sock IT! Oral Pain Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063148
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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