# K250456: Dentemp Pro-Comfort Dental Guard

- Pathway: 510(k) (Traditional)
- Applicant: Doc Brands, Inc.
- Decided: May 19, 2025 after 90 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.
No later device cites it as a predicate yet.
0 of 5 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 5.

## Indications for use
Dentemp Pro-Comfort is indicated for protection against nighttime teeth grinding (bruxism). It is intended to reduce damage to teeth and prevent the noise associated with teeth grinding and bruxism.

Source page: https://510kreport.com/device/K250456
Methodology: https://510kreport.com/methodology