510(k) · Cleared
ClearedGumease Dental Mouthpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedevice, Ltd. · KKO Ring, Teething, Fluid-Filled
Cleared on Nov 5, 2007 as substantially equivalent to K963666 (Kick Ice, Inc., 1996) and 2 other predicates after a 98-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Nov 5, 2007
- Review
- 98 days
- Class
- Class II
- Product code
- KKO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K963666 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK963666 Instant Cold PackKick Ice, Inc. · 1996
- This deviceK072082 Gumease Dental MouthpieceBiomedevice, Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963666 | Instant Cold Pack | Kick Ice, Inc. | 1996 | — |
| 0 (this device) | K072082 | Gumease Dental Mouthpiece | Biomedevice, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 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 KKO? 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? (3)
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 |
|---|---|---|---|
| * | K963666 | Instant Cold PackSummary page 1…act Person: Brice Yoder, Office of the Chairman ate of Summary: 7-27-07 evice Name: gumEase ® dental mouthpiece lassification Name: Not Classified redicate Device: a. K963666 - Instant Cold Pack by Kick Ice, Inc. b. K970399 - Kwik KoldTM Peri Cold Pack by Allegiance Healthcare Corporation. c. K… | 1996 |
| * | K970399 | Kwik Kold Peri Cold Pack (Catalog Number TBD)Summary page 1…of Summary: 7-27-07 evice Name: gumEase ® dental mouthpiece lassification Name: Not Classified redicate Device: a. K963666 - Instant Cold Pack by Kick Ice, Inc. b. K970399 - Kwik KoldTM Peri Cold Pack by Allegiance Healthcare Corporation. c. K002066 - Freezer Teether by Cool Baby Inc.… | 1997 |
| * | K002066 | Freezer TeetherSummary page 1…Classified redicate Device: a. K963666 - Instant Cold Pack by Kick Ice, Inc. b. K970399 - Kwik KoldTM Peri Cold Pack by Allegiance Healthcare Corporation. c. K002066 - Freezer Teether by Cool Baby Inc. I of 2… | 2000 |
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?
- None of the 3 ancestors has a recall.
How does its category compare?
All KKO devicesKKO Ring, Teething, Fluid-Filled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · KKO
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · KKO
240in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KKO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KKO
1in 2020
MAUDE reports naming product code KKO, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 5 | 147 | 2 | 0 |
| 2010 | 4 | 240 | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The gumEase® dental mouthpiece provides temporary relief from oral discomfort resulting from dental work, brace pain, denture irritation, post surgical pain or minor oral trauma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072082 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072082: Gumease Dental Mouthpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072082
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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