510(k) · Cleared

Cleared

Reach Antibacterial Toothbrush

K971589510(k) TraditionalCleared Jul 24, 199784-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

Personal Products Co. · EFW Toothbrush, Manual

Cleared on Jul 24, 1997 as substantially equivalent to K950993 (John O. Butler, 1995) after an 84-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.

Decided: Jul 24, 1997
Review: 84 days
Class: Class I
Product code: EFW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K950993 (1995). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK950993 Butler G.U.M. Antibacterial ToothbrushJohn O. Butler · 1995
This deviceK971589 Reach Antibacterial ToothbrushPersonal Products Co. · 1997
Descendant · cites it directly · 1 of its ownK020776 Medoral Hygienic Toothbrush with Dentosan FilamentsCoronet Group North America, LLC · 2002
Descendant · 2 generations on · 0 of its ownK022900 Butler Gum Vari-Clean Power ToothbrushesJohn O. Butler Co. · 2002

Most influential descendants

Showing 2 of 2 · See all

K020776Medoral Hygienic Toothbrush with Dentosan FilamentsCoronet Group North America, LLC · 2002 · cites it directly1descendant
K022900Butler Gum Vari-Clean Power ToothbrushesJohn O. Butler Co. · 2002 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950993	Butler G.U.M. Antibacterial Toothbrush	John O. Butler	1995	—
0 (this device)	K971589	Reach Antibacterial Toothbrush	Personal Products Co.	1997	—
+1	K020776	Medoral Hygienic Toothbrush with Dentosan Filaments	Coronet Group North America, LLC	2002	—
+2	K022900	Butler Gum Vari-Clean Power Toothbrushes	John O. Butler Co.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0

FIG. 1 — Lineage of K971589, 1995–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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? (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	Applicant	Decided	Recalls
*	K950993	Butler G.U.M. Antibacterial Toothbrush Summary page 1 …othbrush -- Class I Device (Ref. 21 CFR § 872.6855) Predicate Device Butler G.U.M. Antibacterial Toothbrush (John O. Butler), a Class I post- amendments 510(k) device (K950993). Intended Use Technological Characteristics/ Description Both the modified device and the predicate device are intended to be…	John O. Butler	1995	—

Also cleared against K950993: 1 other device →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K020776	Medoral Hygienic Toothbrush with Dentosan Filaments	Coronet Group North America, LLC	2002	1

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?

Its one ancestor has no recall.
Of its descendants, K020776 (Coronet Group North America, LLC, 2002) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K950993.

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

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	6
2008	1	—	10
2009	0	—	9
2010	0	—	2
2011	1	—	13
2012	1	—	145
2013	1	—	60
2014	0	—	23
2015	0	—	48
2016	0	—	35
2017	0	—	68
2018	0	—	109
2019	0	—	115
2020	0	—	113
2021	0	—	120
2022	0	—	327
2023	0	—	99
2024	0	—	87
2025	0	—	71
2026	0	—	—

What is it indicated for?

REACH® Antibacterial Toothbrush is used to remove adherent plaque and food debris from teeth to reduce tooth decay. This device is made of a shaft (handle) with synthetic bristles attached at one end. An antibacterial agent has been added to the handle portion. The antibacterial activity is limited to the handle of the toothbrush,

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/K971589 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971589: Reach Antibacterial Toothbrush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971589

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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