510(k) · Cleared
ClearedOral-B Dental Floss with Fluoride
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oral-B Laboratories · JES Floss, Dental
Cleared on Jan 28, 1993 after a 94-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jan 28, 1993
- Review
- 94 days
- Class
- Class I
- Product code
- JES
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK925409 Oral-B Dental Floss with FluorideOral-B Laboratories · 1993
- Descendant · cites it directly · 3 of its ownK935440 Johnson & Johnson Fluoride Dental Floss, Mint WaxedJohnson & Johnson Consumer Products, Inc. · 1994
- Descendant · cites it directly · 1 of its ownK952091 Vutler G.U.M. with FluorideJohn O. Butler Co. · 1995
- Descendant · 2 generations on · 0 of its ownK130186 Dentek Easy Brush with FluorideDen Tek Oral Care, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK102053 Butler Calci-Flor Prophylaxis PasteSunstar Americas, Inc. · 2011
Most influential descendants
Showing 4 of 4 · See all- K935440Johnson & Johnson Fluoride Dental Floss, Mint WaxedJohnson & Johnson Consumer Products, Inc. · 1994 · cites it directly3descendants
- K952091Vutler G.U.M. with FluorideJohn O. Butler Co. · 1995 · cites it directly1descendant
- K130186Dentek Easy Brush with FluorideDen Tek Oral Care, Inc. · 2013 · 2 generations on0descendants
- K102053Butler Calci-Flor Prophylaxis PasteSunstar Americas, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925409 | Oral-B Dental Floss with Fluoride | Oral-B Laboratories | 1993 | — |
| +1 | K935440 | Johnson & Johnson Fluoride Dental Floss, Mint Waxed | Johnson & Johnson Consumer Products, Inc. | 1994 | — |
| +1 | K952091 | Vutler G.U.M. with Fluoride | John O. Butler Co. | 1995 | — |
| +2 | K130186 | Dentek Easy Brush with Fluoride | Den Tek Oral Care, Inc. | 2013 | — |
| +2 | K102053 | Butler Calci-Flor Prophylaxis Paste | Sunstar Americas, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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 JES? 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? (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 |
|---|---|---|---|
| * | — | Oral-B Dental Floss Named without a submission number |
What descends from it? (4)
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?
- Of its descendants, K935440 (Johnson & Johnson Consumer Products, Inc., 1994) has gone furthest, with 3 descendants of its own.
How does its category compare?
All JES devicesJES Floss, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JES
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · JES
Too few JES 510(k)s in any year since 2007 to give a median.
Recalls per year · JES
No recall names JES since 2007.
Adverse event reports per year · JES
5in 2025
MAUDE reports naming product code JES, 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 | 12 |
| 2009 | 1 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 23 |
| 2012 | 0 | — | 0 | 98 |
| 2013 | 0 | — | 0 | 75 |
| 2014 | 0 | — | 0 | 84 |
| 2015 | 0 | — | 0 | 45 |
| 2016 | 0 | — | 0 | 43 |
| 2017 | 0 | — | 0 | 50 |
| 2018 | 0 | — | 0 | 52 |
| 2019 | 0 | — | 0 | 52 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 32 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The primary mode of action of Oral-B Dental Floss With Fluoride is to mechanically remove plaque and food particles from between the teeth.
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/K925409 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925409: Oral-B Dental Floss with Fluoride.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925409
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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