510(k) · Cleared

Cleared

Dentek Easy Brush with Fluoride

K130186510(k) TraditionalCleared Jul 15, 2013171-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

Den Tek Oral Care, Inc. · EFW Toothbrush, Manual

Cleared on Jul 15, 2013 as substantially equivalent to K942633 (Oral-B Laboratories, 1995) and 1 other predicate after a 171-day review. Its family tree reaches back 2 generations to 1993.

Decided: Jul 15, 2013
Review: 171 days
Class: Class I
Product code: EFW
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K925409 (1993). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK925409 Oral-B Dental Floss with FluorideOral-B Laboratories · 1993
1 generation backK935440 Johnson & Johnson Fluoride Dental Floss, Mint WaxedJohnson & Johnson Consumer Products, Inc. · 1994
This deviceK130186 Dentek Easy Brush with FluorideDen Tek Oral Care, Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	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	—
0 (this device)	K130186	Dentek Easy Brush with Fluoride	Den Tek Oral Care, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

FIG. 1 — Lineage of K130186, 1993–2013Source: 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? (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	Applicant	Decided	Recalls
*	K942633	Oral-B Interdental Woodsticks with Fluoride Summary page 1 …rdental brush Classification Name Manual toothbrush Classification Product Code EFW, Class I Predicate Devices Oral-B Woodsticks with Fluoride (K942633) and "Johnson & Johnson Fluoride Dental Floss, Mint Waxed" (K935440). Purpose of the Traditional 510(k) notice. The…	Oral-B Laboratories	1995	—
*	K935440	Johnson & Johnson Fluoride Dental Floss, Mint Waxed Summary page 1 …on Product Code EFW, Class I Predicate Devices Oral-B Woodsticks with Fluoride (K942633) and "Johnson & Johnson Fluoride Dental Floss, Mint Waxed" (K935440). Purpose of the Traditional 510(k) notice. The Easy Brush with fluoride is a modification to DenTek Oral Care Inc.'s Eas…	Johnson & Johnson Consumer Products, Inc.	1994	—
†	K122331	Cavity Varnish	Dentsply International, Inc.	2012	—

What descends from it?

No later submission names this one as a predicate yet.

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 20 years and passes through 3 companies; a new generation was cleared every 19.4 years on median.
None of the 3 ancestors has a recall.

How does its category compare?

All EFW devices

EFW Toothbrush, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

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?

The Easy Brush with fluoride is intended to mechanically remove plaque and food particles from between teeth to reduce tooth decay. It is to be used with an in and out motion to clean interdental spaces, as it is done with dental floss.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130186 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130186: Dentek Easy Brush 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/K130186

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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