# K123849: New Comfort-Fit Dental Guard

- Pathway: 510(k) (Special)
- Applicant: Den Tek Oral Care, Inc.
- Decided: Jan 10, 2013 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: 3 generations back to K022809 (2003). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081669: Improved Comfort-Fit Nightguard, Den Tek Oral Care, Inc. (2008) Summary page 1.
- K071404: Sleep Right - Select, Low Profile and Advance, Power Products, Inc.-Splintek (2007) Summary page 1.

## Indications for use
The New Comfort-Fit® Dental Guard is indicated for use 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/K123849
Methodology: https://510kreport.com/methodology