510(k) · Cleared

Cleared

Oral-B Dental Tape with Fluoride

K925408510(k) TraditionalCleared Jan 28, 199394-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

Cleared on Jan 28, 1993 after a 94-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: Jan 28, 1993
Review: 94 days
Class: Class I
Product code: JES
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK925408 Oral-B Dental Tape with FluorideOral-B Laboratories · 1993
Descendant · cites it directly · 1 of its ownK952091 Vutler G.U.M. with FluorideJohn O. Butler Co. · 1995
Descendant · 2 generations on · 0 of its ownK102053 Butler Calci-Flor Prophylaxis PasteSunstar Americas, Inc. · 2011

Most influential descendants

Showing 2 of 2 · See all

K952091Vutler G.U.M. with FluorideJohn O. Butler Co. · 1995 · cites it directly1descendant
K102053Butler Calci-Flor Prophylaxis PasteSunstar Americas, Inc. · 2011 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K925408	Oral-B Dental Tape with Fluoride	Oral-B Laboratories	1993	—
+1	K952091	Vutler G.U.M. with Fluoride	John O. Butler Co.	1995	—
+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

FIG. 1 — Lineage of K925408, 1993–2011Source: 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 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? (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
*	—	Oral-B Dental Tape Named without a submission number			—

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
K952091	Vutler G.U.M. with Fluoride	John O. Butler Co.	1995	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?

Of its descendants, K952091 (John O. Butler Co., 1995) has gone furthest, with 1 descendant 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

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	1
2008	0	—	12
2009	1	—	10
2010	0	—	1
2011	0	—	23
2012	0	—	98
2013	0	—	75
2014	0	—	84
2015	0	—	45
2016	0	—	43
2017	0	—	50
2018	0	—	52
2019	0	—	52
2020	0	—	32
2021	0	—	32
2022	0	—	8
2023	0	—	3
2024	0	—	6
2025	0	—	5
2026	0	—	—

What is it indicated for?

The primary mode of action of Oral-B Dental Tape With Fluoride is to mechanically remove plaque and food particles from between the teeth.

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/K925408 · printed Nov 6, 2026

Cite this page

510(k) Report. “K925408: Oral-B Dental Tape 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/K925408

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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