510(k) · Cleared
ClearedPuraStat-OM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3-D Matrix, Inc. · OLR Oral Wound Dressing
Cleared on Oct 8, 2021 as substantially equivalent to K063148 (Merlin Group Dba Mcmerlin Dental Company, 2007) after a 254-day review. Its family tree reaches back 3 generations to 1995. 4 later devices descend from it.
- Decided
- Oct 8, 2021
- Review
- 254 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953423 (1995). 6 ancestors in all, the oldest K933741 (1994). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK953423 Casrrasyn Oral Wound DressingCarrington Laboratories, Inc. · 1995
- 2 generations backK012126 The Salicept Oral PatchCarrington Laboratories, Inc. · 2001
- 1 generation backK063148 Sock IT! Oral Pain GelMerlin Group Dba Mcmerlin Dental Company · 2007
- This deviceK210211 PuraStat-OM3-D Matrix, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK213552 PuraStat-RM3-D Matrix, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK242634 PuraStat3-D Matrix Europe SAS · 2025
- Descendant · 3 generations on · 1 of its ownK253923 PuraStat3-D Matrix Europe SAS · 2026
- Descendant · 2 generations on · 0 of its ownK261504 PuraStat-RM3-D Matrix, Inc. · 2026
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953423 | Casrrasyn Oral Wound Dressing | Carrington Laboratories, Inc. | 1995 | — |
| −2 | K012126 | The Salicept Oral Patch | Carrington Laboratories, Inc. | 2001 | — |
| −1 | K063148 | Sock IT! Oral Pain Gel | Merlin Group Dba Mcmerlin Dental Company | 2007 | — |
| 0 (this device) | K210211 | PuraStat-OM | 3-D Matrix, Inc. | 2021 | — |
| +1 | K213552 | PuraStat-RM | 3-D Matrix, Inc. | 2022 | — |
| +2 | K242634 | PuraStat | 3-D Matrix Europe SAS | 2025 | — |
| +3 | K253923 | PuraStat | 3-D Matrix Europe SAS | 2026 | — |
| +2 | K261504 | PuraStat-RM | 3-D Matrix, Inc. | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K063148 | Sock IT! Oral Pain GelSummary page 4…ed Product Code: MGQ Panel: General and Plastic Surgery 3. PREDICATE DEVICE Predicate Device: McMerlin Dental Company’s SOCKIT!® Oral Hydrogel Wound Dressing (K063148) Reference Device: 3-D Matrix, Inc. PuraDerm Gel (K143058) 4. DEVICE DESCRIPTION PuraStat-OM is a sterile gel composed… | 2007 |
| † | K143058 | PuraDerm Gel | 2015 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213552 | PuraStat-RM | 2022 | 3 |
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 26 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K213552 (3-D Matrix, Inc., 2022) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K063148.
How does its category compare?
All OLR devicesOLR Oral Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
PuraStat-OM adheres to oral tissue and forms a protective barrier over the wound to prevent further irritation and contamination. It provides a 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 (may be caused by chemotherapy or radiotherapy)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210211 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210211: PuraStat-OM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210211
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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