# K191033: LunaGuard Nighttime Dental Protector

- Pathway: 510(k) (Traditional)
- Applicant: Mckeon Products
- Decided: Aug 5, 2019 after 109 days
- Product code: OBR (Mouthguard, Over-The-Counter)
- 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 K022809 (2003). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121272: Protech Dent, Akervall Technologies, Inc. (2012) Summary page 4.

## Indications for use
The LunaGuard™ Nighttime Dental Protector is indicated for use in protecting the teeth and reducing damage caused by bruxism or nighttime grinding.

Source page: https://510kreport.com/device/K191033
Methodology: https://510kreport.com/methodology