# K132469: The Bite Guard

- Pathway: 510(k) (Abbreviated)
- Applicant: International Profit Builders, Inc.
- Decided: Feb 28, 2014 after 205 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: 5 generations back to K882303 (1989). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091792: Rest Assured Generation II Dental Protector, Ranir Corporation (2009) Summary page 4.
- K072147: Den Tek Comfort Fit Nightguard, Den Tek Oral Care, Inc. (2007) Summary page 2.
- K113326: Oral B Plus Outlast Night Time Dental Guard, Oralabs, Inc. (2012) Summary page 2.

## Indications for use
The Bite Guard is used to prevent grinding of the teeth, jaw clenching and to reduce damage to the teeth from grinding.

Source page: https://510kreport.com/device/K132469
Methodology: https://510kreport.com/methodology