# K971794: Elastic Mandibular Advancement (Ema) Appliance

- Pathway: 510(k) (Traditional)
- Applicant: Frantz Design, Inc.
- Decided: Sep 29, 1997 after 137 days
- Product code: LRK (Device, Anti-Snoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K880956 (1988). 2 ancestors in all.
35 later devices descend from it; 10 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902790: NAPA, G-Ortho Lab (1990) Summary page 1.
- K880956: Snoar (TM) Open Airway Appliance, Kent J. Toone, D.D.S. (1988) Summary page 1.

## Most influential descendants
- K113201: Narval CC (2011), 15 descendants of its own
- K013808: Sleepbite (2002), 11 descendants of its own
- K143244: The Panthera Anti-Snoring Device (2014), 9 descendants of its own
- K052862: Full Breath Sleep Appliance - AB (Anterior Bite) (2005), 9 descendants of its own
- K061228: Full Breath Sleep Appliance with Posterior Tongue Depressor (2006), 8 descendants of its own

## Indications for use
Indications for use: Treatment of nasal respiratory dysfunction of obstructive sleep apnea and snoring in those patients where advancement of the mandible and opening the bite can increase the patients air space.

Source page: https://510kreport.com/device/K971794
Methodology: https://510kreport.com/methodology