510(k) Report

510(k) · Cleared

Cleared

Vutler G.U.M. with Fluoride

K952091510(k) TraditionalCleared Jun 28, 199556-day reviewClass I21 CFR 872.6390

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

John O. Butler Co. · JES Floss, Dental

Cleared on Jun 28, 1995 as substantially equivalent to K925408 (Oral-B Laboratories, 1993) and 2 other predicates after a 56-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.

Decided
Jun 28, 1995
Review
56 days
Class
Class I
Product code
JES
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K925409 (1993). 3 ancestors in all, the oldest K925408 (1993). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1993: 1 other ancestor2011: 1 descendant clearedK925409 · Oral-B Dental Floss with Fluoride · Oral-B Laboratories · 1993K935440 · Johnson & Johnson Fluoride Dental Floss, Mint Waxed · Johnson & Johnson Consumer Products, Inc. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant K935440 · Johnson & Johnson Fluoride Dental Floss, Mint Waxed · Johnson & Johnson Consumer Products, Inc. · 1994K925409 · Oral-B Dental Floss with Fluoride · Oral-B Laboratories · 19930
  1. Root · 2 generations backK925409 Oral-B Dental Floss with FluorideOral-B Laboratories · 1993
  2. 1 generation backK935440 Johnson & Johnson Fluoride Dental Floss, Mint WaxedJohnson & Johnson Consumer Products, Inc. · 1994
  3. This deviceK952091 Vutler G.U.M. with FluorideJohn O. Butler Co. · 1995
  4. Descendant · cites it directly · 0 of its ownK102053 Butler Calci-Flor Prophylaxis PasteSunstar Americas, Inc. · 2011

Most influential descendants

Showing 1 of 1 · See all
  • K102053Butler Calci-Flor Prophylaxis PasteSunstar Americas, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K925409Oral-B Dental Floss with FluorideOral-B Laboratories1993—
−1K935440Johnson & Johnson Fluoride Dental Floss, Mint WaxedJohnson & Johnson Consumer Products, Inc.1994—
0 (this device)K952091Vutler G.U.M. with FluorideJohn O. Butler Co.1995—
+1K102053Butler Calci-Flor Prophylaxis PasteSunstar Americas, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
FIG. 1 — Lineage of K952091, 1993–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K925408Oral-B Dental Tape with Fluoride
Summary page 3
…t variations of flavor / no flavor, and wax / no wax. C. The Predicate Products The predicate products used in this Premarket Notification are: 510 (k) Number Product 925408 Oral B Mint Waxed Floss with Fluoride 925409 Oral B Mint Waxed Tape with Fluoride 935440 Johnson and Johnson REACH Dentotape with…
Oral-B Laboratories1993—
*K925409Oral-B Dental Floss with Fluoride
Summary page 3
…no wax. C. The Predicate Products The predicate products used in this Premarket Notification are: 510 (k) Number Product 925408 Oral B Mint Waxed Floss with Fluoride 925409 Oral B Mint Waxed Tape with Fluoride 935440 Johnson and Johnson REACH Dentotape with Fluoride ———————-- John O. Butler, Butler W…
Oral-B Laboratories1993—
*K935440Johnson & Johnson Fluoride Dental Floss, Mint Waxed
Summary page 3
…icate products used in this Premarket Notification are: 510 (k) Number Product 925408 Oral B Mint Waxed Floss with Fluoride 925409 Oral B Mint Waxed Tape with Fluoride 935440 Johnson and Johnson REACH Dentotape with Fluoride ———————-- John O. Butler, Butler Weave Product (exempt 21 CFR 872.6390) D. De…
Johnson & Johnson Consumer Products, Inc.1994—
*—John O. Butler, Butler Weave Product
Named without a submission number
—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102053Butler Calci-Flor Prophylaxis PasteSunstar Americas, Inc.20110

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 2 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K102053 (Sunstar Americas, Inc., 2011) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JES devices

JES Floss, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JES

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

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

2007: 12008: 122009: 102010: 12011: 232012: 982013: 752014: 842015: 452016: 432017: 502018: 522019: 522020: 322021: 322022: 82023: 32024: 62025: 5
2007high 98 (2012) · low 1 (2007)2025

MAUDE reports naming product code JES, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—012
20091—010
20100—01
20110—023
20120—098
20130—075
20140—084
20150—045
20160—043
20170—050
20180—052
20190—052
20200—032
20210—032
20220—08
20230—03
20240—06
20250—05
20260—0—

What is it indicated for?

These products are intended to be used for the removal of adherent plaque and debris from the teeth.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from John O. Butler Co.

4 FDA decisions under this applicant name. See the company

  • K022900Butler Gum Vari-Clean Power ToothbrushesJohn O. Butler Co. · 2002
  • K974761Butler Antibacterial Interdental ToothbrushJohn O. Butler Co. · 1998
  • K943942Trav-Ler KitJohn O. Butler Co. · 1995

Recent decisions in JES

The JES category page

  • K091964Crest Glide Clinical Gum Protection Dental FlossProcter & Gamble Co. · 2009
  • K964976Flossbrush with FluorideFlossbrush Interdental Cleaner and Applicator · 1997
  • K963746Ids Dental Floss with Sodium Fluoride Microdent Dental Floss with Sodium Fluoride AP-24 Dental Floss with…Whitehill Oral Technologies, Inc. · 1996
  • K944034Perio-Med Dental FlossWhitehill Oral Technologies, Inc. · 1995
  • K951917Johnson & Johnson Easy Slide Dental FlossJohnson & Johnson Consumer Products, Inc. · 1995

https://510kreport.com/device/K952091 · printed Nov 4, 2026

Cite this page

510(k) Report. “K952091: Vutler G.U.M. with Fluoride.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952091

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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