# K981546: Nti Clenching Suppression System

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Jul 15, 1998 after 76 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.
39 later devices descend from it; 3 cite it directly.
0 of 40 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
- K040315: Myohealth Clenching Inhibitor (2004), 11 descendants of its own
- K082723: Grindguard (2009), 10 descendants of its own

## Indications for use
For the prevention of chronic tension and temporal mandibular joint syndrome that is caused by chronic 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/K981546
Methodology: https://510kreport.com/methodology