# K111066: Migra Tab, Quicksplint Migraine

- Pathway: 510(k) (Traditional)
- Applicant: Migratherapy, LLC
- Decided: Nov 22, 2011 after 218 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
Longest line of descent: 2 generations back to K882303 (1989). 5 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040315: Myohealth Clenching Inhibitor, Mci-Myohealth Systems (2004) Summary page 3.
- K014079: DR. Hays Bite Guard, Inventive Resources, Inc. (2002) Summary page 3.
- (no number) Custom fabricated full occlusal coverage bite plate (pre-1972 device): named in the summary without a submission number

## Most influential descendants
- K170985: Urbanek Device (2017), 4 descendants of its own
- K182820: The POD (2019), 3 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

## Indications for use
Protection of teeth and restorations from injury due to bruxisni or clenching. Relief of bruxism related headaches and pains. Treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated headaches and pains.

Source page: https://510kreport.com/device/K111066
Methodology: https://510kreport.com/methodology