510(k) · Cleared

Cleared

Enfresh Tongue Brush

K973424510(k) TraditionalCleared Dec 9, 199790-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

Enfresh Products, LLC · LCN Scraper, Tongue

Cleared on Dec 9, 1997 as substantially equivalent to K901408 (Garry Laboratories, Inc., 1990) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1996.

Decided: Dec 9, 1997
Review: 90 days
Class: Class I
Product code: LCN
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K961574 (1996). 3 ancestors in all, the oldest K901408 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK961574 Tongue ScrapperU.S. Dentek Corp. · 1996
1 generation backK970042 Ooli-U (Tongue Scraper)Telefax Intl. · 1997
This deviceK973424 Enfresh Tongue BrushEnfresh Products, LLC · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K961574	Tongue Scrapper	U.S. Dentek Corp.	1996	—
−1	K970042	Ooli-U (Tongue Scraper)	Telefax Intl.	1997	—
0 (this device)	K973424	Enfresh Tongue Brush	Enfresh Products, LLC	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0

FIG. 1 — Lineage of K973424, 1996–1997Source: 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 LCN? 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
*	K901408	The Tongue Brush Summary page 1 …997 Name of Device Enfresh Tongue Brush Common or Usual Name Tongue brush Classification Name Tongue brush Predicate Devices (1) Garry Laboratories’s The Tongue Brush (K901408); and (2) Telefax International’s OOLI-U (Tongue Scraper) (K970042) \\\DC - 71604/300 - 0508469.01 Intended Use…	Garry Laboratories, Inc.	1990	—
*	K970042	Ooli-U (Tongue Scraper) Summary page 1 …e brush Classification Name Tongue brush Predicate Devices (1) Garry Laboratories’s The Tongue Brush (K901408); and (2) Telefax International’s OOLI-U (Tongue Scraper) (K970042) \\\DC - 71604/300 - 0508469.01 Intended Use The Enfresh Tongue Brush and the predicate devices are intended to…	Telefax Intl.	1997	—

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 1 year and passes through 3 companies; a new generation was cleared every 9 months on median.
None of the 3 ancestors has a recall.

How does its category compare?

All LCN devices

LCN Scraper, Tongue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LCN

FDA has decided no LCN device since 2007.

Median 510(k) review, days · LCN

Too few LCN 510(k)s in any year since 2007 to give a median.

Recalls per year · LCN

No recall names LCN since 2007.

Adverse event reports per year · LCN

1in 2024

2007high 1 (2024) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	1
2025	—	0
2026	—	—

What is it indicated for?

To remove plaque and food debris from the surface of the tongue.

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/K973424 · printed Nov 5, 2026

Cite this page

510(k) Report. “K973424: Enfresh Tongue Brush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973424

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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