510(k) · Cleared
ClearedDental Air Force Home Dental Cleaning System, Model NO. 0020001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Air Force, Inc. · EFS Unit, Oral Irrigation
Cleared on Oct 25, 2000 after a 166-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.
- Decided
- Oct 25, 2000
- Review
- 166 days
- Class
- Class I
- Product code
- EFS
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK001493 Dental Air Force Home Dental Cleaning System, Model NO. 0020001Air Force, Inc. · 2000
- Descendant · cites it directly · 7 of its ownK040416 Sonicare Advance Toothbrush, Model 4900Philips Oral Healthcare, Inc. · 2004
- Descendant · 2 generations on · 3 of its ownK061351 Oral-B Sonic CompleteBraun GmbH · 2006
- Descendant · 3 generations on · 2 of its ownK073224 Oral-B Sub-Brand Manual ToothbrushProcter & Gamble · 2008
- Descendant · 2 generations on · 2 of its ownK061199 Oral B Professionalcare Series, Oral B Advancepower SeriesBraun GmbH · 2006
- Descendant · 3 generations on · 1 of its ownK141018 Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive…Procter & Gamble Co. · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K040416Sonicare Advance Toothbrush, Model 4900Philips Oral Healthcare, Inc. · 2004 · cites it directly7descendants
- K061351Oral-B Sonic CompleteBraun GmbH · 2006 · 2 generations on3descendants
- K073224Oral-B Sub-Brand Manual ToothbrushProcter & Gamble · 2008 · 3 generations on2descendants
- K061199Oral B Professionalcare Series, Oral B Advancepower SeriesBraun GmbH · 2006 · 2 generations on2descendants
- K141018Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive Power Toothbrush Kit…Procter & Gamble Co. · 2014 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001493 | Dental Air Force Home Dental Cleaning System, Model NO. 0020001 | Air Force, Inc. | 2000 | — |
| +1 | K040416 | Sonicare Advance Toothbrush, Model 4900 | Philips Oral Healthcare, Inc. | 2004 | — |
| +2 | K061351 | Oral-B Sonic Complete | Braun GmbH | 2006 | — |
| +3 | K073224 | Oral-B Sub-Brand Manual Toothbrush | Procter & Gamble | 2008 | — |
| +2 | K061199 | Oral B Professionalcare Series, Oral B Advancepower Series | Braun GmbH | 2006 | — |
| +3 | K141018 | Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive Power… | Procter & Gamble Co. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EFS? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040416 | Sonicare Advance Toothbrush, Model 4900 | 2004 | 7 |
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?
- Of its descendants, K040416 (Philips Oral Healthcare, Inc., 2004) has gone furthest, with 7 descendants of its own.
How does its category compare?
All EFS devicesEFS Unit, Oral Irrigation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EFS
FDA has decided no EFS device since 2007.
Median 510(k) review, days · EFS
Too few EFS 510(k)s in any year since 2007 to give a median.
Recalls per year · EFS
No recall names EFS since 2007.
Adverse event reports per year · EFS
9in 2025
MAUDE reports naming product code EFS, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 16 |
| 2021 | 0 | — | 0 | 18 |
| 2022 | 0 | — | 0 | 21 |
| 2023 | 0 | — | 0 | 34 |
| 2024 | 0 | — | 0 | 31 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K001493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001493: Dental Air Force Home Dental Cleaning System, Model NO. 0020001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001493
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026