510(k) Report

510(k) · Cleared

Cleared

Butler G.U.M. Antibacterial Toothbrush

K950993510(k) TraditionalCleared Jun 2, 199591-day reviewClass I21 CFR 872.6855

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

John O. Butler · EFW Toothbrush, Manual

Cleared on Jun 2, 1995 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Jun 2, 1995
Review
91 days
Class
Class I
Product code
EFW
Recalls
None
Predicates
0

4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared1997: 1 descendant cleared2002: 2 descendants cleared1995200020052010201520202025
  1. This deviceK950993 Butler G.U.M. Antibacterial ToothbrushJohn O. Butler · 1995
  2. Descendant · cites it directly · 2 of its ownK973236 Crest Toothbrush with MicroshieldProcter & Gamble Co. · 1998
  3. Descendant · cites it directly · 2 of its ownK971589 Reach Antibacterial ToothbrushPersonal Products Co. · 1997
  4. Descendant · 2 generations on · 1 of its ownK020776 Medoral Hygienic Toothbrush with Dentosan FilamentsCoronet Group North America, LLC · 2002
  5. Descendant · 3 generations on · 0 of its ownK022900 Butler Gum Vari-Clean Power ToothbrushesJohn O. Butler Co. · 2002

Most influential descendants

Showing 4 of 4 · See all
  • K973236Crest Toothbrush with MicroshieldProcter & Gamble Co. · 1998 · cites it directly2descendants
  • K971589Reach Antibacterial ToothbrushPersonal Products Co. · 1997 · cites it directly2descendants
  • K020776Medoral Hygienic Toothbrush with Dentosan FilamentsCoronet Group North America, LLC · 2002 · 2 generations on1descendant
  • K022900Butler Gum Vari-Clean Power ToothbrushesJohn O. Butler Co. · 2002 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950993Butler G.U.M. Antibacterial ToothbrushJohn O. Butler1995—
+1K973236Crest Toothbrush with MicroshieldProcter & Gamble Co.1998—
+1K971589Reach Antibacterial ToothbrushPersonal Products Co.1997—
+2K020776Medoral Hygienic Toothbrush with Dentosan FilamentsCoronet Group North America, LLC2002—
+3K022900Butler Gum Vari-Clean Power ToothbrushesJohn O. Butler Co.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
200220
FIG. 1 — Lineage of K950993, 1995–2002Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K973236Crest Toothbrush with MicroshieldProcter & Gamble Co.19982
K971589Reach Antibacterial ToothbrushPersonal Products Co.19972

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, K973236 (Procter & Gamble Co., 1998) has gone furthest, with 2 descendants of its own.

How does its category compare?

All EFW devices

EFW Toothbrush, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EFW

1in 2013

2008: 12011: 12012: 12013: 1
2007high 1 (2008) · low 0 (2007)2026

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

2007: 62008: 102009: 92010: 22011: 132012: 1452013: 602014: 232015: 482016: 352017: 682018: 1092019: 1152020: 1132021: 1202022: 3272023: 992024: 872025: 71
2007high 327 (2022) · low 2 (2010)2025

MAUDE reports naming product code EFW, 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—06
20081—010
20090—09
20100—02
20111—013
20121—0145
20131—060
20140—023
20150—048
20160—035
20170—068
20180—0109
20190—0115
20200—0113
20210—0120
20220—0327
20230—099
20240—087
20250—071
20260—0—

More from John O. Butler

2 FDA decisions under this applicant name. See the company

  • K874194Protect Drops/Same as K874070John O. Butler · 1987

Recent decisions in EFW

The EFW category page

  • K130186Dentek Easy Brush with FluorideDen Tek Oral Care, Inc. · 2013
  • K121165Beam Brush/Beam AppBeam Technologies, LLC · 2012
  • K102871Silver Care Anitbacterial ToothbrushPiave Spazzolificio S.P.A. · 20111 recall
  • K073224Oral-B Sub-Brand Manual ToothbrushProcter & Gamble · 2008
  • K021383Zeodyne Toothbrush with Agion AntimicrobialAgion Technologies, LLC · 2002

https://510kreport.com/device/K950993 · printed Nov 3, 2026

Cite this page

510(k) Report. “K950993: Butler G.U.M. Antibacterial Toothbrush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K950993

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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