510(k) · Cleared
ClearedMyohealth Clenching Inhibitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mci-Myohealth Systems · MQC Mouthguard, Prescription
Cleared on Aug 27, 2004 as substantially equivalent to K981546 (Heraeus Kulzer, Inc., 1998) after a 200-day review. Its family tree reaches back 1 generation to 1998. 11 later devices descend from it.
- Decided
- Aug 27, 2004
- Review
- 200 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981546 (1998). 11 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK981546 Nti Clenching Suppression SystemHeraeus Kulzer, Inc. · 1998
- This deviceK040315 Myohealth Clenching InhibitorMci-Myohealth Systems · 2004
- Descendant · cites it directly · 7 of its ownK111066 Migra Tab, Quicksplint MigraineMigratherapy, LLC · 2011
- Descendant · 2 generations on · 4 of its ownK170985 Urbanek DeviceTmj Services, LLC · 2017
- Descendant · cites it directly · 4 of its ownK102909 Somnobrux SplintsSomnomed, Inc. · 2011
- Descendant · 3 generations on · 3 of its ownK182820 The PODAdvanced Facialdontics, LLC · 2019
- Descendant · 2 generations on · 2 of its ownK203596 Panthera Occlusal AppliancePanthera Dental, Inc. · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K111066Migra Tab, Quicksplint MigraineMigratherapy, LLC · 2011 · cites it directly7descendants
- K170985Urbanek DeviceTmj Services, LLC · 2017 · 2 generations on4descendants
- K102909Somnobrux SplintsSomnomed, Inc. · 2011 · cites it directly4descendants
- K182820The PODAdvanced Facialdontics, LLC · 2019 · 3 generations on3descendants
- K203596Panthera Occlusal AppliancePanthera Dental, Inc. · 2021 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981546 | Nti Clenching Suppression System | Heraeus Kulzer, Inc. | 1998 | — |
| 0 (this device) | K040315 | Myohealth Clenching Inhibitor | Mci-Myohealth Systems | 2004 | — |
| +1 | K111066 | Migra Tab, Quicksplint Migraine | Migratherapy, LLC | 2011 | — |
| +2 | K170985 | Urbanek Device | Tmj Services, LLC | 2017 | — |
| +1 | K102909 | Somnobrux Splints | Somnomed, Inc. | 2011 | — |
| +3 | K182820 | The POD | Advanced Facialdontics, LLC | 2019 | — |
| +2 | K203596 | Panthera Occlusal Appliance | Panthera Dental, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 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 15.3 · 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? (1)
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 |
|---|---|---|---|
| * | K981546 | Nti Clenching Suppression SystemSummary page 2…nhibitor (NTI Clenching Suppression System, K981546 Protection of teeth and For the prevention of chronic res… | 1998 |
What descends from it? (11)
See all 113 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?
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
1. Protection of teeth and restorations from the forces of bruxism.
2. For the prevention of TMJ syndrome through reduction of trigeminally innervated muscular activity.
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/K040315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040315: Myohealth Clenching Inhibitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040315
Report an extraction error
Are you the manufacturer?
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