510(k) · Cleared
ClearedOral-B Sub-Brand Manual Toothbrush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Procter & Gamble · EFW Toothbrush, Manual
Cleared on Feb 6, 2008 as substantially equivalent to K061351 (Braun GmbH, 2006) after an 83-day review. Its family tree reaches back 3 generations to 1992. 2 later devices descend from it.
- Decided
- Feb 6, 2008
- Review
- 83 days
- Class
- Class I
- Product code
- EFW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K921773 (1992). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK921773 TX Electric ToothbrushOptiva Corp. · 1992
- 2 generations backK040416 Sonicare Advance Toothbrush, Model 4900Philips Oral Healthcare, Inc. · 2004
- 1 generation backK061351 Oral-B Sonic CompleteBraun GmbH · 2006
- This deviceK073224 Oral-B Sub-Brand Manual ToothbrushProcter & Gamble · 2008
- Descendant · cites it directly · 0 of its ownK121165 Beam Brush/Beam AppBeam Technologies, LLC · 2012
- Descendant · cites it directly · 0 of its ownK091964 Crest Glide Clinical Gum Protection Dental FlossProcter & Gamble Co. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921773 | TX Electric Toothbrush | Optiva Corp. | 1992 | — |
| −2 | K040416 | Sonicare Advance Toothbrush, Model 4900 | Philips Oral Healthcare, Inc. | 2004 | — |
| −1 | K061351 | Oral-B Sonic Complete | Braun GmbH | 2006 | — |
| 0 (this device) | K073224 | Oral-B Sub-Brand Manual Toothbrush | Procter & Gamble | 2008 | — |
| +1 | K121165 | Beam Brush/Beam App | Beam Technologies, LLC | 2012 | — |
| +1 | K091964 | Crest Glide Clinical Gum Protection Dental Floss | Procter & Gamble Co. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K061351 | Oral-B Sonic CompleteSummary page 1…CFR 872.6855) ILegally Marketed Predicate Devices: Toothbrush. Manual EFW (21 CRF 872.6855) Toothbrush Power JFIQ (21 CUR 872.6865) K061351 lDevice D)eseription and Technical Characterislics: The Oral- B®i: toothbrush is a manlcii toolhbrush comprised of a shaft with… | 2006 |
| * | — | Toothbrush, Manual EFW Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K121165 (Beam Technologies, LLC, 2012) 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. 2008, this device’s year, is highlighted.
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?
To promote good oral hygiene including plaque removal and treating and preventing
gingivitis.
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/K073224 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073224: Oral-B Sub-Brand Manual Toothbrush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073224
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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