510(k) · Cleared
ClearedThe POD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Facialdontics, LLC · MQC Mouthguard, Prescription
Cleared on Jul 17, 2019 as substantially equivalent to K170985 (Tmj Services, LLC, 2017) after a 286-day review. Its family tree reaches back 4 generations to 1989. 3 later devices descend from it.
- Decided
- Jul 17, 2019
- Review
- 286 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K882303 (1989). 8 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 3 generations backK014079 DR. Hays Bite GuardInventive Resources, Inc. · 2002
- 2 generations backK111066 Migra Tab, Quicksplint MigraineMigratherapy, LLC · 2011
- 1 generation backK170985 Urbanek DeviceTmj Services, LLC · 2017
- This deviceK182820 The PODAdvanced Facialdontics, LLC · 2019
- 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 · 3 generations on · 0 of its ownK230548 Myoaligner ApplianceMyohealth Technologies, LLC · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −3 | K014079 | DR. Hays Bite Guard | Inventive Resources, Inc. | 2002 | — |
| −2 | K111066 | Migra Tab, Quicksplint Migraine | Migratherapy, LLC | 2011 | — |
| −1 | K170985 | Urbanek Device | Tmj Services, LLC | 2017 | — |
| 0 (this device) | K182820 | The POD | Advanced Facialdontics, LLC | 2019 | — |
| +1 | K203596 | Panthera Occlusal Appliance | Panthera Dental, Inc. | 2021 | — |
| +2 | K230495 | Serena Sleep Night Guard | Meris Investment Group | 2023 | — |
| +3 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K170985 | Urbanek DeviceSummary page 4…oduct Code: OCO Review Panel: Dental 510(k) Number: K182820 3. Predicate Devices Primary Predicate: Urbanek Device (K170985) Reference Devices: Luco Hybrid OSA Appliance (K160477) NTI Clenching Suppression Sy… | 2017 |
| † | K160477 | The Luco Hybrid OSA Appliance | 2016 |
| † | K981546 | Nti Clenching Suppression System | 1998 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203596 | Panthera Occlusal Appliance | 2021 | 2 |
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 30 years and passes through 5 companies; a new generation was cleared every 9.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K203596 (Panthera Dental, Inc., 2021) has gone furthest, with 2 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. 2019, 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 POD® 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/K182820 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182820: The POD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182820
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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