# K180933: DenTek Ultimate Dental Guard

- Pathway: 510(k) (Traditional)
- Applicant: Medtech Products, Inc.
- Decided: Sep 17, 2018 after 160 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: 4 generations back to K053580 (2006). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091660: Custom Comfort Nightguard Version 2, Den Tek Oral Care, Inc. (2009) Summary page 4.

## Most influential descendants
- 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 DenTek Ultimate™ Dental Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.

Source page: https://510kreport.com/device/K180933
Methodology: https://510kreport.com/methodology