510(k) · Cleared
ClearedUnik Tongue Cleaner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unik Products, Inc. · LCN Scraper, Tongue
Cleared on Jan 14, 1999 as substantially equivalent to K972644 (Intl. Dental Design Specialists, Inc., 1997) after an 86-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Jan 14, 1999
- Review
- 86 days
- Class
- Class I
- Product code
- LCN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961660 (1996). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK961660 Tongue CleanerJack Conrey · 1996
- 1 generation backK972644 Breath-SO-Fresh Tongue CleanerIntl. Dental Design Specialists, Inc. · 1997
- This deviceK983683 Unik Tongue CleanerUnik Products, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK992270 Miraclebreath Tongue CleanerStellar Labs, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K992270Miraclebreath Tongue CleanerStellar Labs, Inc. · 1999 · cites it directly0descendants
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) | K983683 | Unik Tongue Cleaner | Unik Products, Inc. | 1999 | — |
| +1 | K992270 | Miraclebreath Tongue Cleaner | Stellar Labs, 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 | 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? (1)
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 |
|---|---|---|---|
| * | K972644 | Breath-SO-Fresh Tongue CleanerSummary page 1…leaner b. Common/Usual Name: Tongue Cleaner or Tongue Scraper c. Classification Name: Scraper, Tongue (per LCN) ; 3. Predicate Device: a. Breath-So-Fresh Tongue Cleaner (K972644) 4. Device Description: This is a device consisting of a molded polypropylene plastic handle, similar in appearance to that of a… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992270 | Miraclebreath Tongue Cleaner | 1999 | 0 |
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 1.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K992270 (Stellar Labs, Inc., 1999) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K972644.
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?
The intended use of the Unik Tongue Cleaner is to remove bacteria from and prevent plague build-up on the tongue to help fight bad breath and promote oral hygiene.
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/K983683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983683: Unik 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/K983683
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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