# K014079: DR. Hays Bite Guard

- Pathway: 510(k) (Traditional)
- Applicant: Inventive Resources, Inc.
- Decided: Feb 22, 2002 after 73 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: 1 generation back to K882303 (1989). 3 ancestors in all.
33 later devices descend from it; 5 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882303: H&M Anti-Snoring Device, Hays & Meade, Inc. (1989) Summary page 1.
- K980953: Accu-Bite Home Kit Discluder, Jerome M. Simon (1998) Summary page 2.
- K981546: Nti Clenching Suppression System, Heraeus Kulzer, Inc. (1998) Summary page 2.

## Most influential descendants
- K024261: Dental Protector (2003), 20 descendants of its own
- 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
- K111066: Migra Tab, Quicksplint Migraine (2011), 7 descendants of its own

## Indications for use
Protecting against tecth grinding, bruxism and jaw clenching. Short-term pain relief from muscle spasm pain due to occlusal interference. For the 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. The device is custom made for the individual.

Source page: https://510kreport.com/device/K014079
Methodology: https://510kreport.com/methodology