510(k) · Cleared
ClearedBreath-SO-Fresh Tongue Cleaner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intl. Dental Design Specialists, Inc. · LCN Scraper, Tongue
Cleared on Sep 11, 1997 as substantially equivalent to K961660 (Jack Conrey, 1996) and 1 other predicate after a 58-day review. Its family tree reaches back 1 generation to 1996. 3 later devices descend from it.
- Decided
- Sep 11, 1997
- Review
- 58 days
- Class
- Class I
- Product code
- LCN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K961660 (1996). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK961660 Tongue CleanerJack Conrey · 1996
- This deviceK972644 Breath-SO-Fresh Tongue CleanerIntl. Dental Design Specialists, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK983683 Unik Tongue CleanerUnik Products, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK992270 Miraclebreath Tongue CleanerStellar Labs, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK990344 Oralgiene Tongue CleanerOralgiene USA, Inc. · 1999
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961660 | Tongue Cleaner | Jack Conrey | 1996 | — |
| 0 (this device) | K972644 | Breath-SO-Fresh Tongue Cleaner | Intl. Dental Design Specialists, Inc. | 1997 | — |
| +1 | K983683 | Unik Tongue Cleaner | Unik Products, Inc. | 1999 | — |
| +2 | K992270 | Miraclebreath Tongue Cleaner | Stellar Labs, Inc. | 1999 | — |
| +1 | K990344 | Oralgiene Tongue Cleaner | Oralgiene USA, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 3 | 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 |
|---|---|---|---|
| * | K961660 | Tongue CleanerSummary page 1…th-So-Fresh Tongue Cleaner Common/Usual Name: Tongue Scraper/Tongue Cleaner Classification Name: Tongue Scraper 3) PREDICATE DEVICES: "The Professional Tongue Cleaner* (K961660) "Oolitt Tongue Cleaner* (K962941) 4) DESCRIPTION OF DEVICE The Breath-So-Fresh tongue cleaner is molded to a modified “spoon-s… | 1996 |
| * | K962941 | Oolitt Tongue Cleaner, Regular Low Ripple/Special High Ripple/Low Ripple Double/High &…Summary page 1…Usual Name: Tongue Scraper/Tongue Cleaner Classification Name: Tongue Scraper 3) PREDICATE DEVICES: "The Professional Tongue Cleaner* (K961660) "Oolitt Tongue Cleaner* (K962941) 4) DESCRIPTION OF DEVICE The Breath-So-Fresh tongue cleaner is molded to a modified “spoon-shape”. One end of the tongue clean… | 1996 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K983683 (Unik Products, Inc., 1999) has gone furthest, with 1 descendant of its own.
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/K972644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972644: Breath-SO-Fresh 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/K972644
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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