510(k) · Cleared
ClearedOralgiene Tongue Cleaner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oralgiene USA, Inc. · LCN Scraper, Tongue
Cleared on May 4, 1999 as substantially equivalent to K973175 (Softek Ent., 1997) and 1 other predicate after an 89-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- May 4, 1999
- Review
- 89 days
- Class
- Class I
- Product code
- LCN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K961660 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961660 | Tongue Cleaner | Jack Conrey | 1996 | — |
| −1 | K972644 | Breath-SO-Fresh Tongue Cleaner | Intl. Dental Design Specialists, Inc. | 1997 | — |
| 0 (this device) | K990344 | Oralgiene Tongue Cleaner | Oralgiene USA, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K973175 | Tongue KleanSummary page 1…: Proprietary Name: Oralgiene Tongue Cleaner Common Name: Tongue Cleaner/Tongue Scraper Classification: Not Known Product Code: LCN PREDICATE DEVICES: Tongue Klean (K973175) Breath-So-Fresh Tongue Cleaner (K972644) DESCRIPTION OF DEVICE The Oralgiene Tongue Cleaner is a “T” shaped manual device used… | 1997 |
| * | K972644 | Breath-SO-Fresh Tongue CleanerSummary page 1…ner Common Name: Tongue Cleaner/Tongue Scraper Classification: Not Known Product Code: LCN PREDICATE DEVICES: Tongue Klean (K973175) Breath-So-Fresh Tongue Cleaner (K972644) DESCRIPTION OF DEVICE The Oralgiene Tongue Cleaner is a “T” shaped manual device used in the same manner as other items already… | 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 3 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All LCN devicesLCN 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
MAUDE reports naming product code LCN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
To remove bacterial plaque and food debris from the surface of the tongue, promoting clean mouth and fresher breath.
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/K990344 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990344: Oralgiene Tongue Cleaner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990344
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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