510(k) Report

510(k) · Cleared

Cleared

Oolitt Tongue Cleaner, Regular Low Ripple/Special High Ripple/Low Ripple Double/High & Low Ripple/Comfort Eze

K962941510(k) TraditionalCleared Oct 8, 199671-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

Deep Trading Corp. · LCN Scraper, Tongue

Cleared on Oct 8, 1996 after a 71-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.

Decided
Oct 8, 1996
Review
71 days
Class
Class I
Product code
LCN
Recalls
None
Predicates
0

5 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared1999: 3 descendants cleared1995200020052010201520202025
  1. This deviceK962941 Oolitt Tongue Cleaner, Regular Low Ripple/Special High Ripple/Low…Deep Trading Corp. · 1996
  2. Descendant · cites it directly · 3 of its ownK972644 Breath-SO-Fresh Tongue CleanerIntl. Dental Design Specialists, Inc. · 1997
  3. Descendant · 2 generations on · 1 of its ownK983683 Unik Tongue CleanerUnik Products, Inc. · 1999
  4. Descendant · cites it directly · 1 of its ownK973175 Tongue KleanSoftek Ent. · 1997
  5. Descendant · cites it directly · 0 of its ownK992270 Miraclebreath Tongue CleanerStellar Labs, Inc. · 1999
  6. Descendant · 2 generations on · 0 of its ownK990344 Oralgiene Tongue CleanerOralgiene USA, Inc. · 1999

Most influential descendants

Showing 5 of 5 · See all
  • K972644Breath-SO-Fresh Tongue CleanerIntl. Dental Design Specialists, Inc. · 1997 · cites it directly3descendants
  • K983683Unik Tongue CleanerUnik Products, Inc. · 1999 · 2 generations on1descendant
  • K973175Tongue KleanSoftek Ent. · 1997 · cites it directly1descendant
  • K992270Miraclebreath Tongue CleanerStellar Labs, Inc. · 1999 · cites it directly0descendants
  • K990344Oralgiene Tongue CleanerOralgiene USA, Inc. · 1999 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K962941Oolitt Tongue Cleaner, Regular Low Ripple/Special High Ripple/Low Ripple…Deep Trading Corp.1996—
+1K972644Breath-SO-Fresh Tongue CleanerIntl. Dental Design Specialists, Inc.1997—
+2K983683Unik Tongue CleanerUnik Products, Inc.1999—
+1K973175Tongue KleanSoftek Ent.1997—
+1K992270Miraclebreath Tongue CleanerStellar Labs, Inc.1999—
+2K990344Oralgiene Tongue CleanerOralgiene USA, Inc.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199930
FIG. 1 — Lineage of K962941, 1996–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (5)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K972644Breath-SO-Fresh Tongue CleanerIntl. Dental Design Specialists, Inc.19973
K973175Tongue KleanSoftek Ent.19971
K992270Miraclebreath Tongue CleanerStellar Labs, Inc.19990

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, K972644 (Intl. Dental Design Specialists, Inc., 1997) has gone furthest, with 3 descendants of its own.

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

2024: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—01
20250—00
20260—0—

Recent decisions in LCN

The LCN category page

  • K992270Miraclebreath Tongue CleanerStellar Labs, Inc. · 1999
  • K990344Oralgiene Tongue CleanerOralgiene USA, Inc. · 1999
  • K983683Unik Tongue CleanerUnik Products, Inc. · 1999
  • K983087Breathtique Tongue ScraperCustom Medical Arts, Inc. · 1998
  • K981808Breathaid Tongue ScraperBreathaid, LLC · 1998

https://510kreport.com/device/K962941 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962941: Oolitt Tongue Cleaner, Regular Low Ripple/Special High Ripple/Low Ripple Double/High & Low Ripple/Comfort Eze.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962941

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026