# K091660: Custom Comfort Nightguard Version 2

- Pathway: 510(k) (Special)
- Applicant: Den Tek Oral Care, Inc.
- Decided: Jun 12, 2009 after 3 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: 3 generations back to K053580 (2006). 3 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083400: Custom Comfort Nightguard, Den Tek Oral Care, Inc. (2008) Summary page 1.
- K063483: Den Tek Nightguard, Den Tek Oral Care, Inc. (2007) Summary page 1.

## Cited in the summary but kept off the family tree
- K1073220: The Doctor's Nightguard Advanced Comfort. Number could not be read Summary page 1.

## Most influential descendants
- K180933: DenTek Ultimate Dental Guard (2018), 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
- K250456: Dentemp Pro-Comfort Dental Guard (2025), 0 descendants of its own
- K172452: Bruxor (2018), 0 descendants of its own

## Indications for use
The Custom Comfort Nightguard Version 2 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/K091660
Methodology: https://510kreport.com/methodology