510(k) · Cleared
ClearedMedoral Hygienic Toothbrush with Dentosan Filaments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coronet Group North America, LLC · EFW Toothbrush, Manual
Cleared on Jun 3, 2002 as substantially equivalent to K971589 (Personal Products Co., 1997) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Jun 3, 2002
- Review
- 84 days
- Class
- Class I
- Product code
- EFW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K950993 (1995). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK950993 Butler G.U.M. Antibacterial ToothbrushJohn O. Butler · 1995
- 1 generation backK971589 Reach Antibacterial ToothbrushPersonal Products Co. · 1997
- This deviceK020776 Medoral Hygienic Toothbrush with Dentosan FilamentsCoronet Group North America, LLC · 2002
- Descendant · cites it directly · 0 of its ownK022900 Butler Gum Vari-Clean Power ToothbrushesJohn O. Butler Co. · 2002
Most influential descendants
Showing 1 of 1 · See all- K022900Butler Gum Vari-Clean Power ToothbrushesJohn O. Butler Co. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950993 | Butler G.U.M. Antibacterial Toothbrush | John O. Butler | 1995 | — |
| −1 | K971589 | Reach Antibacterial Toothbrush | Personal Products Co. | 1997 | — |
| 0 (this device) | K020776 | Medoral Hygienic Toothbrush with Dentosan Filaments | Coronet Group North America, LLC | 2002 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K971589 | Reach Antibacterial ToothbrushSummary page 1…e n t Classification Name: Manual Toothbrush (Class 1 Device Ref21CFR 872.6855) Predicate Devices: Reach Antibacterial Toothbrush K971589 Crest Toothbrush with Microshield K973236 Butler… | 1997 |
| * | K973236 | Crest Toothbrush with MicroshieldSummary page 1…Predicate Devices: Reach Antibacterial Toothbrush K971589 Crest Toothbrush with Microshield K973236 Butler Antibacterial Interdental Toothbrush -7476 1 Device Description: The Medoral Hygi… | 1998 |
| Kept off the family tree | K974761 | FDA’s K974761 is Butler Antibacterial Interdental Toothbrush Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1998 |
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 |
|---|---|---|---|
| K022900 | Butler Gum Vari-Clean Power Toothbrushes | 2002 | 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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K022900 (John O. Butler Co., 2002) has gone furthest, with 0 descendants of its own.
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 Medoral Hygienic Toothbrush with DENTOSANB Filaments is a toothbrush to remove plaque and debris fkom the teeth and prevent tooth decay. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on and between the bristles after and between uses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020776 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020776: Medoral Hygienic Toothbrush with Dentosan Filaments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020776
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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