# K024261: Dental Protector

- Pathway: 510(k) (Traditional)
- Applicant: Dental Concepts, LLC
- Decided: Mar 26, 2003 after 93 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 K882303 (1989). 4 ancestors in all.
20 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014079: DR. Hays Bite Guard, Inventive Resources, Inc. (2002)

## Most influential descendants
- K073220: The Doctor's Nightguard Advanced Comfort (2007), 17 descendants of its own
- K082723: Grindguard (2009), 10 descendants of its own
- K123161: Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard Elite (2013), 9 descendants of its own
- K063229: Rest Assured Nite Protector (2006), 7 descendants of its own
- K133037: Grindguard (2014), 6 descendants of its own

## Indications for use
The Dental Concepts Bite Plate is indicated for protection against bruxism (nighttime teeth grinding) and jaw clenching during sleep, short-term pain relief from muscle spasm due to occlusal interference, and prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the posterior mandibular and maxillary teeth by the temporalis muscle.

Source page: https://510kreport.com/device/K024261
Methodology: https://510kreport.com/methodology