# K150492: Ora-GUARD Dental Grind Guard

- Pathway: 510(k) (Traditional)
- Applicant: Bite Tech, Inc.
- Decided: Feb 19, 2016 after 359 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)
- K091660: Custom Comfort Nightguard Version 2, Den Tek Oral Care, Inc. (2009) Summary page 4.

## Indications for use
The Ora-GUARD Dental Grind Guard is a device that is indicated for protection against bruxism, nighttime teeth grinding, and jaw clenching. It is intended to reduce damage to teeth and prevent the noise associated with teeth grinding and bruxism.

Source page: https://510kreport.com/device/K150492
Methodology: https://510kreport.com/methodology