510(k) · Cleared
ClearedDSG Relaxer Splint
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sentage Corporation D/B/A/ Dental Services Group · MQC Mouthguard, Prescription
Cleared on Mar 18, 2003 after a 223-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Mar 18, 2003
- Review
- 223 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK022627 DSG Relaxer SplintSentage Corporation D/B/A/ Dental Services Group · 2003
- Descendant · cites it directly · 4 of its ownK102909 Somnobrux SplintsSomnomed, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK203596 Panthera Occlusal AppliancePanthera Dental, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK230495 Serena Sleep Night GuardMeris Investment Group · 2023
- Descendant · 2 generations on · 0 of its ownK230548 Myoaligner ApplianceMyohealth Technologies, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK143623 Narval BruxResmed Sas · 2015
Most influential descendants
Showing 5 of 5 · See all- K102909Somnobrux SplintsSomnomed, Inc. · 2011 · cites it directly4descendants
- K203596Panthera Occlusal AppliancePanthera Dental, Inc. · 2021 · 2 generations on2descendants
- K230495Serena Sleep Night GuardMeris Investment Group · 2023 · 3 generations on1descendant
- K230548Myoaligner ApplianceMyohealth Technologies, LLC · 2024 · 2 generations on0descendants
- K143623Narval BruxResmed Sas · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022627 | DSG Relaxer Splint | Sentage Corporation D/B/A/ Dental Services Group | 2003 | — |
| +1 | K102909 | Somnobrux Splints | Somnomed, Inc. | 2011 | — |
| +2 | K203596 | Panthera Occlusal Appliance | Panthera Dental, Inc. | 2021 | — |
| +3 | K230495 | Serena Sleep Night Guard | Meris Investment Group | 2023 | — |
| +2 | K230548 | Myoaligner Appliance | Myohealth Technologies, LLC | 2024 | — |
| +2 | K143623 | Narval Brux | Resmed Sas | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102909 | Somnobrux Splints | 2011 | 4 |
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?
- Of its descendants, K102909 (Somnomed, Inc., 2011) has gone furthest, with 4 descendants of its own.
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?
The DSG Relaxer Splint is an acrylic device to be used in the treatment of medically diagnosed migraine pain as well as migraine associated tension headaches and relieving bruxism and temporomandibular joint syndrome through trigeminally innervated muscular activity.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K022627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022627: DSG Relaxer Splint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022627
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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