# K110468: Freeway Comfort Bite Guard

- Pathway: 510(k) (Traditional)
- Applicant: Randmark Dental Products, LLC
- Decided: Aug 5, 2011 after 169 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: 1 generation back to K071404 (2007). 1 ancestor in all.
10 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071404: Sleep Right - Select, Low Profile and Advance, Power Products, Inc.-Splintek (2007) Summary page 3.

## Cited in the summary but kept off the family tree
- K010876: Nti Tension Suppression System, Nti-Tss, Inc. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K123161: Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard Elite (2013), 9 descendants of its own
- K133037: Grindguard (2014), 6 descendants of its own
- K181099: Bright Guard (2019), 5 descendants of its own
- K221369: FBCC Night Guard (2022), 3 descendants of its own
- K251778: Remi Custom Night Guard (2025), 1 descendant of its own

## Indications for use
Protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding. 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 temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle

Source page: https://510kreport.com/device/K110468
Methodology: https://510kreport.com/methodology