# K121365: Thermoformed Mouthguards

- Pathway: 510(k) (Traditional)
- Applicant: Glidewell Laboratories-Sleep Devices Group
- Decided: Nov 20, 2012 after 197 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). 8 ancestors in all.
4 later devices descend from it; 2 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)
- K053580: Doctor's Nightguard, Dental Concepts, LLC (2006) Summary page 1.
- K022809: EZ Splint & EZ Splint PM, Power Products, Inc.-Splintek (2003) Summary page 1.
- K014079: DR. Hays Bite Guard, Inventive Resources, Inc. (2002) Summary page 4.

## Most influential descendants
- K210011: JS Dental Lab Mouth Guard (2021), 2 descendants of its own
- K241369: LIJIA Night Guard (2024), 1 descendant of its own
- K243516: Remi Custom Night Guard (2025), 0 descendants of its own
- K202465: Night Guard (2020), 0 descendants of its own

## Indications for use
The Thermoformed Mouthguards are intended for protection against bruxism and nighttime teeth grinding. They create a barrier between the upper and lower dentition to protect the patient's overall occlusion.

Source page: https://510kreport.com/device/K121365
Methodology: https://510kreport.com/methodology