# K022809: EZ Splint & EZ Splint PM

- Pathway: 510(k) (Traditional)
- Applicant: Power Products, Inc.-Splintek
- Decided: Oct 17, 2003 after 420 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.
46 later devices descend from it; 6 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN100024: Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch. Our reading of the summary gave K104029, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN100024, Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch (), granted —; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K010876: Nti Tension Suppression System, Nti-Tss, Inc. (2001)

## Most influential descendants
- K072147: Den Tek Comfort Fit Nightguard (2007), 19 descendants of its own
- K123161: Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard Elite (2013), 9 descendants of its own
- K082301: Grind NO More (2008), 8 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
Protection against teeth grinding, bruxism and jaw clenching. Short-term pain relief from muscle spasm 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.

Source page: https://510kreport.com/device/K022809
Methodology: https://510kreport.com/methodology