# K010876: Nti Tension Suppression System

- Pathway: 510(k) (Traditional)
- Applicant: Nti-Tss, Inc.
- Decided: Jun 20, 2001 after 89 days
- Product code: OCO (Mouthguard, Migraine/Tension Headache)
- 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.
63 later devices descend from it; 6 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022809: EZ Splint & EZ Splint PM (2003), 46 descendants of its own
- K072147: Den Tek Comfort Fit Nightguard (2007), 19 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
- K052862: Full Breath Sleep Appliance - AB (Anterior Bite) (2005), 9 descendants of its own

Source page: https://510kreport.com/device/K010876
Methodology: https://510kreport.com/methodology