# K183315: CustMBite Dental Guard

- Pathway: 510(k) (Traditional)
- Applicant: Dental Choice Holdings, LLC
- Decided: Aug 23, 2019 after 266 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: 4 generations back to K053580 (2006). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113326: Oral B Plus Outlast Night Time Dental Guard, Oralabs, Inc. (2012) Summary page 4.

## Indications for use
The CustMBite Dental Guard is an over-the-counter dental guard indicated for the protection against bruxism — the nighttime clenching and grinding of the teeth. It is intended for use in the mouth at night to reduce damage to the teeth and to prevent the noise associated with teeth grinding. The CustMBite Dental Guard is intended for individuals age 18 and older.

Source page: https://510kreport.com/device/K183315
Methodology: https://510kreport.com/methodology