510(k) · Cleared
ClearedZeodyne Toothbrush with Agion Antimicrobial
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agion Technologies, LLC · EFW Toothbrush, Manual
Cleared on Jul 17, 2002 after a 76-day review. The FDA summary names its predicate without a number.
- Decided
- Jul 17, 2002
- Review
- 76 days
- Class
- Class I
- Product code
- EFW
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 EFW? 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? (2)
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 |
|---|---|---|---|
| * | — | Crest Toothbrush with MicroShield Named without a submission number | |
| * | — | Disposable Stethoscope Diaphragm with AgION Antimicrobial Compound Named without a submission number |
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.
How does its category compare?
All EFW devicesEFW Toothbrush, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EFW
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · EFW
Too few EFW 510(k)s in any year since 2007 to give a median.
Recalls per year · EFW
No recall names EFW since 2007.
Adverse event reports per year · EFW
71in 2025
MAUDE reports naming product code EFW, 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 | 6 |
| 2008 | 1 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 145 |
| 2013 | 1 | — | 0 | 60 |
| 2014 | 0 | — | 0 | 23 |
| 2015 | 0 | — | 0 | 48 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 0 | — | 0 | 68 |
| 2018 | 0 | — | 0 | 109 |
| 2019 | 0 | — | 0 | 115 |
| 2020 | 0 | — | 0 | 113 |
| 2021 | 0 | — | 0 | 120 |
| 2022 | 0 | — | 0 | 327 |
| 2023 | 0 | — | 0 | 99 |
| 2024 | 0 | — | 0 | 87 |
| 2025 | 0 | — | 0 | 71 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Zeodyne Toothbrush with AgION'rM Antimicrobial is intended to remove adberent plaque and, food debris from the teeth. The addition of the antimicrobial agent is to prevent the growth of bacteria on the toothbrush between brushings. The antimicrobial treatment is not intended to have m y effect on the user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021383 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021383: Zeodyne Toothbrush with Agion Antimicrobial.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021383
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026