# K113326: Oral B Plus Outlast Night Time Dental Guard

- Pathway: 510(k) (Traditional)
- Applicant: Oralabs, Inc.
- Decided: Jun 27, 2012 after 230 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 K053580 (2006). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083400: Custom Comfort Nightguard, Den Tek Oral Care, Inc. (2008) Summary page 1.

## Most influential descendants
- K183315: CustMBite Dental Guard (2019), 0 descendants of its own
- K132469: The Bite Guard (2014), 0 descendants of its own

## Indications for use
The Oral B plus Scope Outlast Nighttime Dental Guard is an Over-the-Counter dental guard indicated for the protection against bruxisin - 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 teeth grinding.

Source page: https://510kreport.com/device/K113326
Methodology: https://510kreport.com/methodology