510(k) · Cleared
ClearedSomnobrux Splints
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Somnomed, Inc. · MQC Mouthguard, Prescription
Cleared on Dec 13, 2011 as substantially equivalent to K040315 (Mci-Myohealth Systems, 2004) and 1 other predicate after a 438-day review. Its family tree reaches back 2 generations to 1998. 4 later devices descend from it.
- Decided
- Dec 13, 2011
- Review
- 438 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K981546 (1998). 3 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK981546 Nti Clenching Suppression SystemHeraeus Kulzer, Inc. · 1998
- 1 generation backK040315 Myohealth Clenching InhibitorMci-Myohealth Systems · 2004
- This deviceK102909 Somnobrux SplintsSomnomed, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK203596 Panthera Occlusal AppliancePanthera Dental, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK230495 Serena Sleep Night GuardMeris Investment Group · 2023
- Descendant · cites it directly · 0 of its ownK230548 Myoaligner ApplianceMyohealth Technologies, LLC · 2024
- Descendant · cites it directly · 0 of its ownK143623 Narval BruxResmed Sas · 2015
Most influential descendants
Showing 4 of 4 · See all- K203596Panthera Occlusal AppliancePanthera Dental, Inc. · 2021 · cites it directly2descendants
- K230495Serena Sleep Night GuardMeris Investment Group · 2023 · 2 generations on1descendant
- K230548Myoaligner ApplianceMyohealth Technologies, LLC · 2024 · cites it directly0descendants
- K143623Narval BruxResmed Sas · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981546 | Nti Clenching Suppression System | Heraeus Kulzer, Inc. | 1998 | — |
| −1 | K040315 | Myohealth Clenching Inhibitor | Mci-Myohealth Systems | 2004 | — |
| 0 (this device) | K102909 | Somnobrux Splints | Somnomed, Inc. | 2011 | — |
| +1 | K203596 | Panthera Occlusal Appliance | Panthera Dental, Inc. | 2021 | — |
| +2 | K230495 | Serena Sleep Night Guard | Meris Investment Group | 2023 | — |
| +1 | K230548 | Myoaligner Appliance | Myohealth Technologies, LLC | 2024 | — |
| +1 | K143623 | Narval Brux | Resmed Sas | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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 MQC? 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 MQC device
- #1 K203000 KeyPrint KeySplint Hardscore 15.4 · 5 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 |
|---|---|---|---|
| * | K040315 | Myohealth Clenching InhibitorSummary page 1…Information: Device Name Manufacturer 510(k) Reference MY0HEALTH CLENCHING MCI-MYOHEALTH SYSTEMS K040315 INHIBITOR a150 know as Bite Soft DSG Relaxer Spint Dental Services Group Sentage K022627… | 2004 |
| * | K022627 | DSG Relaxer SplintSummary page 1…CLENCHING MCI-MYOHEALTH SYSTEMS K040315 INHIBITOR a150 know as Bite Soft DSG Relaxer Spint Dental Services Group Sentage K022627 Corporation, dba. Dental Services Group.… | 2003 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K203596 (Panthera Dental, Inc., 2021) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K040315.
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MQC
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQC
185in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQC
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQC
7in 2025
MAUDE reports naming product code MQC, 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 | 4 | 79 | 0 | 9 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 4 | 194 | 0 | 2 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 3 | 234 | 0 | 5 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 2 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 71 |
| 2019 | 5 | 286 | 0 | 62 |
| 2020 | 4 | 204 | 0 | 46 |
| 2021 | 7 | 158 | 0 | 111 |
| 2022 | 5 | 120 | 0 | 137 |
| 2023 | 6 | 230 | 1 | 62 |
| 2024 | 8 | 249 | 0 | 8 |
| 2025 | 4 | 185 | 0 | 7 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The SomnoBrux Splints are Used for the protection of teeth and restorations from the forces of Bruxism.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102909 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102909: Somnobrux Splints.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102909
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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