510(k) · Cleared
ClearedCleanse.Freshen.GO; Aligner Cleansing Towelette and Dental Appliance Cleanser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oral Health Technologies, LLC · EFT Cleanser, Denture, Over The Counter
Cleared on May 23, 2008 after a 79-day review. The FDA summary names its predicate without a number.
- Decided
- May 23, 2008
- Review
- 79 days
- Class
- Class I
- Product code
- EFT
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 EFT? 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 |
|---|---|---|---|
| * | — | Efferdent Anti-Bacterial Denture Cleanser Named without a submission number |
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.
How does its category compare?
All EFT devicesEFT Cleanser, Denture, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · EFT
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · EFT
Too few EFT 510(k)s in any year since 2007 to give a median.
Recalls per year · EFT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EFT
11in 2025
MAUDE reports naming product code EFT, 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 | 9 |
| 2008 | 1 | — | 0 | 12 |
| 2009 | 0 | — | 0 | 17 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 0 | — | 0 | 25 |
| 2012 | 0 | — | 0 | 18 |
| 2013 | 0 | — | 0 | 31 |
| 2014 | 0 | — | 0 | 13 |
| 2015 | 0 | — | 0 | 20 |
| 2016 | 0 | — | 0 | 67 |
| 2017 | 0 | — | 0 | 83 |
| 2018 | 0 | — | 0 | 79 |
| 2019 | 0 | — | 0 | 55 |
| 2020 | 0 | — | 0 | 68 |
| 2021 | 0 | — | 0 | 74 |
| 2022 | 0 | — | 0 | 40 |
| 2023 | 0 | — | 1 | 44 |
| 2024 | 0 | — | 0 | 42 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Cleanse. Freshen. Go. Aligner Cleansing Towelette is indicated for OTC use to remove oral debris and kill odor causing bacteria associated with removable dental appliances.
Cleanse.Freshen.Go. Dental Appliance Cleanser is indicated for OTC use to remove oral debris and kill odor causing bacteria associated with removable dental appliances.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080631: Cleanse.Freshen.GO; Aligner Cleansing Towelette and Dental Appliance Cleanser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080631
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026