# K202465: Night Guard

- Pathway: 510(k) (Traditional)
- Applicant: 3D Diagnostix, Inc.
- Decided: Nov 25, 2020 after 90 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: 3 generations back to K882303 (1989). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121365: Thermoformed Mouthguards, Glidewell Laboratories-Sleep Devices Group (2012) Summary page 4.

## Indications for use
Night Guard is indicated for protection against bruxism or nighttime teeth grinding. It creates a barrier between upper and lower dentition to protect the patient's overall occlusion.

Source page: https://510kreport.com/device/K202465
Methodology: https://510kreport.com/methodology