# K210011: JS Dental Lab Mouth Guard

- Pathway: 510(k) (Traditional)
- Applicant: Ampower Dental Laboratories, LLC
- Decided: Jul 16, 2021 after 193 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.
2 later devices descend from it; 1 cites it directly.
0 of 12 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.

## Most influential descendants
- K241369: LIJIA Night Guard (2024), 1 descendant of its own
- K243516: Remi Custom Night Guard (2025), 0 descendants of its own

## Indications for use
The JS Dental Lab Mouth Guard is intended for protection against bruxism and 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/K210011
Methodology: https://510kreport.com/methodology