# K121272: Protech Dent

- Pathway: 510(k) (Traditional)
- Applicant: Akervall Technologies, Inc.
- Decided: Oct 15, 2012 after 171 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: 2 generations back to K022809 (2003). 6 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072147: Den Tek Comfort Fit Nightguard, Den Tek Oral Care, Inc. (2007) Summary page 1.

## Most influential descendants
- K172223: SleepRight ProRx Custom Dental Guard (2017), 3 descendants of its own
- K193577: SleepRight ProRx Custom Dental Guard (2020), 2 descendants of its own
- K250743: Remvia NightGuard (2025), 0 descendants of its own
- K212706: SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard (2021), 0 descendants of its own
- K191033: LunaGuard Nighttime Dental Protector (2019), 0 descendants of its own

## Indications for use
The Akervall Technologies mouthguards (ProTech Dent, are indicated for use in protecting the teeth and reduce damage caused by bruxism or nighttime grinding.

Source page: https://510kreport.com/device/K121272
Methodology: https://510kreport.com/methodology