# K072147: Den Tek Comfort Fit Nightguard

- Pathway: 510(k) (Special)
- Applicant: Den Tek Oral Care, Inc.
- Decided: Aug 30, 2007 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: 1 generation back to K022809 (2003). 5 ancestors in all.
19 later devices descend from it; 6 cite it directly.
0 of 25 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 1.
- K022809: EZ Splint & EZ Splint PM, Power Products, Inc.-Splintek (2003) Summary page 2.

## Most influential descendants
- K082301: Grind NO More (2008), 8 descendants of its own
- K121272: Protech Dent (2012), 5 descendants of its own
- K091175: Grind NO More Version 2 and 3 (2009), 4 descendants of its own
- K172223: SleepRight ProRx Custom Dental Guard (2017), 3 descendants of its own
- K193577: SleepRight ProRx Custom Dental Guard (2020), 2 descendants of its own

## Indications for use
The DenTek Comfort Fit 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/K072147
Methodology: https://510kreport.com/methodology