510(k) · Cleared
ClearedBrace Eze
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Udent, Inc. · EGD Wax, Dental, Intraoral
Cleared on Feb 11, 2002 as substantially equivalent to K924024 (Heraeus Kulzer, Inc., 1992) after a 40-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.
- Decided
- Feb 11, 2002
- Review
- 40 days
- Class
- Class I
- Product code
- EGD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924024 (1992). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K131396Wired Mouth Protector (WMP)Elba Laboratories, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924024 | Ortho Wax | Heraeus Kulzer, Inc. | 1992 | — |
| 0 (this device) | K020009 | Brace Eze | Udent, Inc. | 2002 | — |
| +1 | K131396 | Wired Mouth Protector (WMP) | Elba Laboratories, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 EGD? 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 |
|---|---|---|---|
| * | K924024 | Ortho WaxSummary page 1…ted devices in the United States. Brace Eze functions in a manner similar to and is intended for the same use as Ortho Wax cleared for marketing for Heraeus Kulzer, Inc (K924024). 8-1 P’ { DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service " C Food and Drug Administration 9200 C… | 1992 |
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 |
|---|---|---|---|
| K131396 | Wired Mouth Protector (WMP) | 2013 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K131396 (Elba Laboratories, Inc., 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EGD devicesEGD Wax, Dental, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EGD
FDA has decided no EGD device since 2007.
Median 510(k) review, days · EGD
Too few EGD 510(k)s in any year since 2007 to give a median.
Recalls per year · EGD
No recall names EGD since 2007.
Adverse event reports per year · EGD
1in 2024
MAUDE reports naming product code EGD, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Brace Eze is intended to provide relief from the discomfort and irritation to the inside of the cheek and lips caused by orthodontic brace.
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/K020009 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020009: Brace Eze.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020009
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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