# K170985: Urbanek Device

- Pathway: 510(k) (Traditional)
- Applicant: Tmj Services, LLC
- Decided: Sep 25, 2017 after 175 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: 3 generations back to K882303 (1989). 7 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K010876: Nti Tension Suppression System, Nti-Tss, Inc. (2001) Summary page 5.
- K111066: Migra Tab, Quicksplint Migraine, Migratherapy, LLC (2011) Summary page 5.

## Most influential descendants
- K182820: The POD (2019), 3 descendants of its own
- K203596: Panthera Occlusal Appliance (2021), 2 descendants of its own
- K230495: Serena Sleep Night Guard (2023), 1 descendant of its own
- K230548: Myoaligner Appliance (2024), 0 descendants of its own

## Indications for use
The Urbanek Device is for the amelioration of clenching and bruxing associated with TMD and is to be used to aid in the relief of symptoms of TMD/TMJ.

Source page: https://510kreport.com/device/K170985
Methodology: https://510kreport.com/methodology