510(k) · Cleared
ClearedJohnson & Johnson Fluoride Dental Floss, Mint Waxed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Consumer Products, Inc. · JES Floss, Dental
Cleared on Feb 3, 1994 as substantially equivalent to K925409 (Oral-B Laboratories, 1993) after an 83-day review. Its family tree reaches back 1 generation to 1993. 3 later devices descend from it.
- Decided
- Feb 3, 1994
- Review
- 83 days
- Class
- Class I
- Product code
- JES
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925409 (1993). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK925409 Oral-B Dental Floss with FluorideOral-B Laboratories · 1993
- This deviceK935440 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 · cites it directly · 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 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925409 | Oral-B Dental Floss with Fluoride | Oral-B Laboratories | 1993 | — |
| 0 (this device) | 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 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K925409 | Oral-B Dental Floss with FluorideSummary page 1…oride Dental Floss 9.0 510(k) SUMMARY JOHNSON & JOHNSON Fluoride Dental Floss, Mint Waxed is substantially equivalent to Oral-B Dental Floss with Fluoride, Mint Waxed (K925409) and JOHNSON & JOHNSON Dental Floss, Mint Waxed (Pre-1976 Medical Device Amendment 510(k) exemption). JOHNSON & JOHNSON Fluoride… | 1993 |
| * | — | JOHNSON & JOHNSON Dental Floss, Mint Waxed Named without a submission number |
What descends from it? (3)
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?
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?
However, the primary mode of action of JOHNSON & JOHNSON Fluoride Dental Floss, Mint Waxed is to mechanically remove plaque and food particles from between the teeth, and along and under the gumline.
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/K935440 · printed Nov 5, 2026
Cite this page
510(k) Report. “K935440: Johnson & Johnson Fluoride Dental Floss, Mint Waxed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K935440
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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