# K080631: Cleanse.Freshen.GO; Aligner Cleansing Towelette and Dental Appliance Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Oral Health Technologies, LLC
- Decided: May 23, 2008 after 79 days
- Product code: EFT (Cleanser, Denture, Over The Counter)
- Device class: 1
- Regulation: 21 CFR 872.3520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Efferdent Anti-Bacterial Denture Cleanser: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K080631
Methodology: https://510kreport.com/methodology