# K980953: Accu-Bite Home Kit Discluder

- Pathway: 510(k) (Traditional)
- Applicant: Jerome M. Simon
- Decided: Oct 7, 1998 after 208 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
No predicates in its family tree.
34 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K014079: DR. Hays Bite Guard (2002), 33 descendants of its own
- 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

## Indications for use
An adjunct device to be used for short-term pain relief from muscle spasm pain due to occlusal interference.

Source page: https://510kreport.com/device/K980953
Methodology: https://510kreport.com/methodology