# K232238: Goyo Mouthpiece S

- Pathway: 510(k) (Traditional)
- Applicant: Dimedikorea
- Decided: Apr 17, 2024 after 264 days
- Product code: OBR (Mouthguard, Over-The-Counter)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K022809 (2003). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133423: Rest Assured Extra Comfort Nite Protector, Ranir, LLC (2013) Summary page 5.

## Indications for use
The Goyo Mouthpiece S is indicated for use as a protection against bruxism or nighttime teeth grinding. The device is designed to reduce tooth damage and reduce the noise associated with bruxism or teeth grinding.

Source page: https://510kreport.com/device/K232238
Methodology: https://510kreport.com/methodology