# K123161: Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard Elite

- Pathway: 510(k) (Traditional)
- Applicant: Smartguard, Inc.
- Decided: Mar 14, 2013 after 156 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: 5 generations back to K882303 (1989). 16 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 26 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 1.
- K022809: EZ Splint & EZ Splint PM, Power Products, Inc.-Splintek (2003) Summary page 1.
- K110468: Freeway Comfort Bite Guard, Randmark Dental Products, LLC (2011) Summary page 1.
- K082723: Grindguard, Grind Guard Technologies, LLC (2009) Summary page 1.

## Cited in the summary but kept off the family tree
- K110066: Aquilion Prime, Toshiba America Medical Systems, In.C (2012). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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
- K253641: Owl Night Guard (2026), 0 descendants of its own

## Indications for use
OTC: Protection against bruxism or night time teeth grinding Reduce damage to the teeth and reduce the noise associated with bruxing and/or grinding Rx: Protection of teeth grinding, bruxism, and jaw clenching. Protection of restorations from injury due to bruxism or clenching. Relief of bruxism related headaches and pains. 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 mandibular and maxillary teeth by the temporalis muscle. Temporary treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated headaches and pains.

Source page: https://510kreport.com/device/K123161
Methodology: https://510kreport.com/methodology