# K260790: G-Series Grind Guard

- Pathway: 510(k) (Traditional)
- Applicant: ASESSO HEALTH, Inc.
- Decided: Jun 25, 2026 after 106 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The G-Series Grind Guard is indicated for protection against bruxism, nighttime teeth grinding and jaw clenching. It is intended to reduce damage to teeth and prevent the noise associated with teeth grinding / bruxism.

Source page: https://510kreport.com/device/K260790
Methodology: https://510kreport.com/methodology