# K083400: Custom Comfort Nightguard

- Pathway: 510(k) (Special)
- Applicant: Den Tek Oral Care, Inc.
- Decided: Dec 11, 2008 after 24 days
- Product code: OBR (Mouthguard, Over-The-Counter)
- 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 K053580 (2006). 2 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063483: Den Tek Nightguard, Den Tek Oral Care, Inc. (2007) Summary page 2.

## Most influential descendants
- K091660: Custom Comfort Nightguard Version 2 (2009), 6 descendants of its own
- K180933: DenTek Ultimate Dental Guard (2018), 2 descendants of its own
- K113326: Oral B Plus Outlast Night Time Dental Guard (2012), 2 descendants of its own
- K231865: Mouth Guard (ATG0603R) (2023), 1 descendant of its own
- K252485: ClenchNoMore  (CNM-1 (Mixed sizing)); ClenchNoMore  (CNM-L (Large size)); ClenchNoMore  (CNM-S (Small size)) (2026), 0 descendants of its own

## Indications for use
The Custom Comfort Nightguard is indicated for use for 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.

Source page: https://510kreport.com/device/K083400
Methodology: https://510kreport.com/methodology