# K090472: Grind Guard

- Pathway: 510(k) (Traditional)
- Applicant: Archtek, Inc.
- Decided: Oct 14, 2009 after 232 days
- Product code: MQC (Mouthguard, Prescription)
- 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: 2 generations back to K053580 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073446: Grind Guard, Archtek, Inc. (2008) Summary page 1.
- K071404: Sleep Right - Select, Low Profile and Advance, Power Products, Inc.-Splintek (2007) Summary page 1.

## Indications for use
a. To protect against tooth damage bruxism and clenching caused by occlusal interferences, b. Provide short term relief from muscle spasm due to occlusal interferences, and c. Prevention of pain and chronic tension of temporomandibular joint syndrome components that are caused by chronic jaw clenching.

Source page: https://510kreport.com/device/K090472
Methodology: https://510kreport.com/methodology