# K063483: Den Tek Nightguard

- Pathway: 510(k) (Traditional)
- Applicant: Den Tek Oral Care, Inc.
- Decided: Jan 23, 2007 after 67 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: 1 generation back to K053580 (2006). 1 ancestor in all.
31 later devices descend from it; 4 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053580: Doctor's Nightguard, Dental Concepts, LLC (2006) Summary page 1.

## Most influential descendants
- K072147: Den Tek Comfort Fit Nightguard (2007), 19 descendants of its own
- K083400: Custom Comfort Nightguard (2008), 10 descendants of its own
- K082301: Grind NO More (2008), 8 descendants of its own
- K091660: Custom Comfort Nightguard Version 2 (2009), 6 descendants of its own
- K121272: Protech Dent (2012), 5 descendants of its own

## Indications for use
The DenTek NightGuard is indicated 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 teeth grinding.

Source page: https://510kreport.com/device/K063483
Methodology: https://510kreport.com/methodology