# K022627: DSG Relaxer Splint

- Pathway: 510(k) (Traditional)
- Applicant: Sentage Corporation D/B/A/ Dental Services Group
- Decided: Mar 18, 2003 after 223 days
- Product code: MQC (Mouthguard, Prescription)
- 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices 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.

## Most influential descendants
- K102909: Somnobrux Splints (2011), 4 descendants of its own
- K203596: Panthera Occlusal Appliance (2021), 2 descendants of its own
- K230495: Serena Sleep Night Guard (2023), 1 descendant of its own
- K230548: Myoaligner Appliance (2024), 0 descendants of its own
- K143623: Narval Brux (2015), 0 descendants of its own

## Indications for use
The DSG Relaxer Splint is an acrylic device to be used in the treatment of medically diagnosed migraine pain as well as migraine associated tension headaches and relieving bruxism and temporomandibular joint syndrome through trigeminally innervated muscular activity.

Source page: https://510kreport.com/device/K022627
Methodology: https://510kreport.com/methodology