# K081669: Improved Comfort-Fit Nightguard

- Pathway: 510(k) (Special)
- Applicant: Den Tek Oral Care, Inc.
- Decided: Jul 10, 2008 after 27 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 K022809 (2003). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072147: Den Tek Comfort Fit Nightguard, Den Tek Oral Care, Inc. (2007) Summary page 1.

## Most influential descendants
- K123849: New Comfort-Fit Dental Guard (2013), 0 descendants of its own

## Indications for use
The DenTek Improved Comfort-Fit 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/K081669
Methodology: https://510kreport.com/methodology