510(k) · Cleared
ClearedWired Mouth Protector (WMP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elba Laboratories, Inc. · PFL Intraoral, Dental Foam Protector
Cleared on Sep 30, 2013 as substantially equivalent to K020009 (Udent, Inc., 2002) after a 138-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Sep 30, 2013
- Review
- 138 days
- Class
- Class I
- Product code
- PFL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K924024 (1992). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 PFL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K020009 | Brace EzeSummary page 1…ctor (WMP) Common Name: Wired Mouth Protector Classification Name: Wax, Dental, !ntraoral; 21 CFR §872.6890 III. PREDICATE DEVICE Brace Eze; K020009 ; Udent, Inc. IV. DEVICE DESCRIPTION The Wired Mouth Protector consists of a non-sterile strip of non-latex foam… | 2002 |
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 21 years and passes through 3 companies; a new generation was cleared every 11.6 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All PFL devicesPFL Intraoral, Dental Foam Protector: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · PFL
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · PFL
Too few PFL 510(k)s in any year since 2007 to give a median.
Recalls per year · PFL
No recall names PFL since 2007.
Adverse event reports per year · PFL
No MAUDE report names PFL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Provides a soft barrier between wired mouth hardware and oral mucosa to help relieve
discomfort for convalescing oral and maxiflofaclal surgery patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131396: Wired Mouth Protector (WMP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131396
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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