# K061122: Night Guard

- Pathway: 510(k) (Traditional)
- Applicant: Alpine Oral Care, LLC
- Decided: Mar 12, 2007 after 322 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.
No later device cites it as a predicate yet.
0 of 9 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 1.

## Indications for use
The Night Guard is intended for protection against bruxism and nighttime teeth grinding. It is intended to reduce damage to teeth and to prevent the noise associated with bruxing and grinding

Source page: https://510kreport.com/device/K061122
Methodology: https://510kreport.com/methodology