510(k) · Cleared

Cleared

Copper Tongue Scraper

K980842510(k) TraditionalCleared May 20, 199877-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

Ontel Products Corp. · LCN Scraper, Tongue

Cleared on May 20, 1998 as substantially equivalent to K961574 (U.S. Dentek Corp., 1996) and 1 other predicate after a 77-day review. Its family tree reaches back 2 generations to 1996.

Decided: May 20, 1998
Review: 77 days
Class: Class I
Product code: LCN
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K961574 (1996). 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 deviceK980842 Copper Tongue ScraperOntel Products Corp. · 1998

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)	K980842	Copper Tongue Scraper	Ontel Products Corp.	1998	—

FIG. 1 — Lineage of K980842, 1996–1998Source: 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
*	K961574	Tongue Scrapper Summary page 1 …Device: Copper Tongue Scraper Common/Usual Name: Tongue Scraper / Tongue Cleaner Classification Name: Scraper, Tongue (per 76LCN) Predicate Device: U.S. Dentek Sakool (K961574) Ooli-U Tongue Scraper (K970042) Description of Device: This device is a U-formed design made of Copper. Intended Use: This dev…	U.S. Dentek Corp.	1996	—
*	K970042	Ooli-U (Tongue Scraper) Summary page 1 …mmon/Usual Name: Tongue Scraper / Tongue Cleaner Classification Name: Scraper, Tongue (per 76LCN) Predicate Device: U.S. Dentek Sakool (K961574) Ooli-U Tongue Scraper (K970042) Description of Device: This device is a U-formed design made of Copper. Intended Use: This device is used to effectively remov…	Telefax Intl.	1997	—

Also cleared against K961574: 1 other device →

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 2 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K961574.

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?

Copper Tongue Scraper's intend use is to remove bacteria and food debris from the tongue surface, hence promoting good oral hygiene. It is intended for over-the-counter point of sale as are other predicate devices.

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/K980842 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980842: Copper Tongue Scraper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980842

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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