# K112868: Dreamgard Rem-Soft, Dreamgard Rem-Lite, Dreamgard Rem-Ultra, Dreamgard Rem-Max

- Pathway: 510(k) (Traditional)
- Applicant: Dreamgard, Inc.
- Decided: Jan 19, 2012 after 111 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: 2 generations back to K981546 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040315: Myohealth Clenching Inhibitor, Mci-Myohealth Systems (2004) Summary page 3.

## Cited in the summary but kept off the family tree
- K1024261: Dental Concepts Bite Plate. Number could not be read Summary page 2.

## Indications for use
Dreamgard nightguards are indicated for protection against bruxism (nighttime teeth grinding) and jaw clenching during sleep, short-term pamn relief from muscle spasm due to occlusal interference, and 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

Source page: https://510kreport.com/device/K112868
Methodology: https://510kreport.com/methodology