510(k) · Cleared
ClearedUrbanek Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tmj Services, LLC · MQC Mouthguard, Prescription
Cleared on Sep 25, 2017 as substantially equivalent to K010876 (Nti-Tss, Inc., 2001) and 1 other predicate after a 175-day review. Its family tree reaches back 3 generations to 1989. 4 later devices descend from it.
- Decided
- Sep 25, 2017
- Review
- 175 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K882303 (1989). 7 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 2 generations backK014079 DR. Hays Bite GuardInventive Resources, Inc. · 2002
- 1 generation backK111066 Migra Tab, Quicksplint MigraineMigratherapy, LLC · 2011
- This deviceK170985 Urbanek DeviceTmj Services, LLC · 2017
- Descendant · cites it directly · 3 of its ownK182820 The PODAdvanced Facialdontics, LLC · 2019
- 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 · 4 generations on · 0 of its ownK230548 Myoaligner ApplianceMyohealth Technologies, LLC · 2024
Most influential descendants
Showing 4 of 4 · See all- K182820The PODAdvanced Facialdontics, LLC · 2019 · cites it directly3descendants
- K203596Panthera Occlusal AppliancePanthera Dental, Inc. · 2021 · 2 generations on2descendants
- K230495Serena Sleep Night GuardMeris Investment Group · 2023 · 3 generations on1descendant
- K230548Myoaligner ApplianceMyohealth Technologies, LLC · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −2 | K014079 | DR. Hays Bite Guard | Inventive Resources, Inc. | 2002 | — |
| −1 | K111066 | Migra Tab, Quicksplint Migraine | Migratherapy, LLC | 2011 | — |
| 0 (this device) | K170985 | Urbanek Device | Tmj Services, LLC | 2017 | — |
| +1 | K182820 | The POD | Advanced Facialdontics, LLC | 2019 | — |
| +2 | K203596 | Panthera Occlusal Appliance | Panthera Dental, Inc. | 2021 | — |
| +3 | K230495 | Serena Sleep Night Guard | Meris Investment Group | 2023 | — |
| +4 | K230548 | Myoaligner Appliance | Myohealth Technologies, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 15.3 · 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? (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 |
|---|---|---|---|
| * | K010876 | Nti Tension Suppression SystemSummary page 5…Page 1 of 4 Predicate Devices: Primary Predicate Device: NTI-TSS Inc.: NTI Tension Suppression System – K010876 (Cleared 06/20/2001) Reference Predicate Device: MigraTherapy, LLC Brux: TMD QuickSplint–… | 2001 |
| * | K111066 | Migra Tab, Quicksplint MigraineSummary page 5…NTI Tension Suppression System – K010876 (Cleared 06/20/2001) Reference Predicate Device: MigraTherapy, LLC Brux: TMD QuickSplint– K111066 (Cleared 11/22/2011) Device Description: The Urbanek Device is an intraoral, maxillary posterior dis-occluding… | 2011 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182820 | The POD | 2019 | 3 |
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 28 years and passes through 4 companies; a new generation was cleared every 9.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K182820 (Advanced Facialdontics, LLC, 2019) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K010876.
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Urbanek Device is for the amelioration of clenching and bruxing associated with TMD and is to be used to aid in the relief of symptoms of TMD/TMJ.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170985 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170985: Urbanek Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170985
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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