510(k) · Cleared
ClearedButler Gum Vari-Clean Power Toothbrushes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
John O. Butler Co. · JEQ Toothbrush, Powered
Cleared on Nov 14, 2002 as substantially equivalent to K020776 (Coronet Group North America, LLC, 2002) after a 72-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Nov 14, 2002
- Review
- 72 days
- Class
- Class I
- Product code
- JEQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K950993 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK950993 Butler G.U.M. Antibacterial ToothbrushJohn O. Butler · 1995
- 2 generations backK971589 Reach Antibacterial ToothbrushPersonal Products Co. · 1997
- 1 generation backK020776 Medoral Hygienic Toothbrush with Dentosan FilamentsCoronet Group North America, LLC · 2002
- This deviceK022900 Butler Gum Vari-Clean Power ToothbrushesJohn O. Butler Co. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950993 | Butler G.U.M. Antibacterial Toothbrush | John O. Butler | 1995 | — |
| −2 | K971589 | Reach Antibacterial Toothbrush | Personal Products Co. | 1997 | — |
| −1 | K020776 | Medoral Hygienic Toothbrush with Dentosan Filaments | Coronet Group North America, LLC | 2002 | — |
| 0 (this device) | K022900 | Butler Gum Vari-Clean Power Toothbrushes | John O. Butler Co. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 JEQ? 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 JEQ device
- #1 K200881 Oral-B iO Test Drive Power Brush Trial Program…score 0.8 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K020776 | Medoral Hygienic Toothbrush with Dentosan FilamentsSummary page 2…The nylon bristles of the Butler GUM@ Vari-CleanTMPower Toothbrush are identical to the bristles cleared by FDA in K020776,whch is the predicate for this Slop).There is no reason to believe that any new questions of safety… | 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 7 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All JEQ devicesJEQ Toothbrush, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JEQ
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · JEQ
Too few JEQ 510(k)s in any year since 2007 to give a median.
Recalls per year · JEQ
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEQ
485in 2025
MAUDE reports naming product code JEQ, 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 | 5 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 0 | — | 4 | 67 |
| 2012 | 0 | — | 0 | 219 |
| 2013 | 0 | — | 2 | 122 |
| 2014 | 1 | — | 0 | 125 |
| 2015 | 0 | — | 0 | 505 |
| 2016 | 0 | — | 0 | 517 |
| 2017 | 0 | — | 0 | 868 |
| 2018 | 0 | — | 0 | 743 |
| 2019 | 0 | — | 0 | 385 |
| 2020 | 1 | — | 0 | 433 |
| 2021 | 0 | — | 0 | 548 |
| 2022 | 0 | — | 0 | 330 |
| 2023 | 0 | — | 0 | 555 |
| 2024 | 0 | — | 0 | 577 |
| 2025 | 0 | — | 0 | 485 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
Butler's Antibacterial Power Toothbrushes are devices that include a handle to be held in the hand and bristles (filaments) at one end to remove adherent plaque and food debris from the teeth to reduce tooth decay. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on and between the bristles between uses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022900 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022900: Butler Gum Vari-Clean Power Toothbrushes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022900
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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