510(k) · Cleared
ClearedElastic Mandibular Advancement (Ema) Appliance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Frantz Design, Inc. · LRK Device, Anti-Snoring
Cleared on Sep 29, 1997 as substantially equivalent to K902790 (G-Ortho Lab, 1990) and 1 other predicate after a 137-day review. Its family tree reaches back 1 generation to 1988. 35 later devices descend from it.
- Decided
- Sep 29, 1997
- Review
- 137 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K880956 (1988). 2 ancestors in all. 35 later devices descend from it, 10 citing it directly.
- Root · 1 generation backK880956 Snoar (TM) Open Airway ApplianceKent J. Toone, D.D.S. · 1988
- This deviceK971794 Elastic Mandibular Advancement (Ema) ApplianceFrantz Design, Inc. · 1997
- Descendant · cites it directly · 15 of its ownK113201 Narval CCResmed Sas · 2011
- Descendant · cites it directly · 11 of its ownK013808 SleepbiteDental Imagineers, LLC · 2002
- Descendant · 2 generations on · 9 of its ownK143244 The Panthera Anti-Snoring DevicePanthera Dental, Inc. · 2014
- Descendant · 2 generations on · 9 of its ownK052862 Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds · 2005
- Descendant · 2 generations on · 8 of its ownK061228 Full Breath Sleep Appliance with Posterior Tongue DepressorBryan Keropian Dds · 2006
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K113201Narval CCResmed Sas · 2011 · cites it directly15descendants
- K013808SleepbiteDental Imagineers, LLC · 2002 · cites it directly11descendants
- K143244The Panthera Anti-Snoring DevicePanthera Dental, Inc. · 2014 · 2 generations on9descendants
- K052862Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds · 2005 · 2 generations on9descendants
- K061228Full Breath Sleep Appliance with Posterior Tongue DepressorBryan Keropian Dds · 2006 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880956 | Snoar (TM) Open Airway Appliance | Kent J. Toone, D.D.S. | 1988 | — |
| 0 (this device) | K971794 | Elastic Mandibular Advancement (Ema) Appliance | Frantz Design, Inc. | 1997 | — |
| +1 | K113201 | Narval CC | Resmed Sas | 2011 | — |
| +1 | K013808 | Sleepbite | Dental Imagineers, LLC | 2002 | — |
| +2 | K143244 | The Panthera Anti-Snoring Device | Panthera Dental, Inc. | 2014 | — |
| +2 | K052862 | Full Breath Sleep Appliance - AB (Anterior Bite) | Bryan Keropian Dds | 2005 | — |
| +2 | K061228 | Full Breath Sleep Appliance with Posterior Tongue Depressor | Bryan Keropian Dds | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LRK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LRK device
- #1 K252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for…score 16.3 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K902790 | NAPASummary page 1…ame: Activator dental appliance Substantial Equivalence Comparison: The Elastic Mandibular Advancement (EMA) appliance is substantially equivalent to the NAPA [510(k) # K902790] and the SNOAR [510(k) # K880956] appliances. Description: The Elastic Mandibular Advancement appliance is a modified functiona… | 1990 |
| * | K880956 | Snoar (TM) Open Airway ApplianceSummary page 1…Substantial Equivalence Comparison: The Elastic Mandibular Advancement (EMA) appliance is substantially equivalent to the NAPA [510(k) # K902790] and the SNOAR [510(k) # K880956] appliances. Description: The Elastic Mandibular Advancement appliance is a modified functional orthodontic appliance. The modi… | 1988 |
What descends from it? (35)
See all 3510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113201 | Narval CC | 2011 | 15 |
| K013808 | Sleepbite | 2002 | 11 |
| K111680 | DR. Greensburg's Hybrid | 2011 | 6 |
| K113516 | Therasom-Cast | 2013 | 2 |
| K232735 | EMA 3D | 2024 | 1 |
| K973884 | Elastic Mandibular Advancement - Titration (Ema-T) Appilance | 1998 | 1 |
| K140435 | Medley Gold | 2014 | 0 |
| K121344 | NU Sleep | 2012 | 0 |
| K120372 | DR Greenburgs Hybrid Vacuum | 2012 | 0 |
| K120371 | DR Greenburgs Hybrid Acrylic | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K113201 (Resmed Sas, 2011) has gone furthest, with 15 descendants of its own.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRK
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LRK
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRK
653in 2025
MAUDE reports naming product code LRK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 3 | 109 | 0 | 1 |
| 2009 | 3 | 88 | 2 | 11 |
| 2010 | 8 | 195 | 0 | 7 |
| 2011 | 10 | 134 | 0 | 69 |
| 2012 | 10 | 142 | 0 | 445 |
| 2013 | 9 | 233 | 0 | 72 |
| 2014 | 11 | 219 | 0 | 49 |
| 2015 | 6 | 117 | 0 | 28 |
| 2016 | 10 | 157 | 0 | 18 |
| 2017 | 7 | 170 | 0 | 32 |
| 2018 | 10 | 200 | 0 | 61 |
| 2019 | 13 | 150 | 0 | 56 |
| 2020 | 5 | 80 | 0 | 24 |
| 2021 | 10 | 126 | 0 | 49 |
| 2022 | 11 | 154 | 0 | 40 |
| 2023 | 5 | 156 | 0 | 50 |
| 2024 | 6 | 254 | 0 | 185 |
| 2025 | 14 | 107 | 1 | 653 |
| 2026 | 10 | 63 | 1 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971794: Elastic Mandibular Advancement (Ema) Appliance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971794
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026