510(k) · Cleared
ClearedThermoformed Mouthguards
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Glidewell Laboratories-Sleep Devices Group · MQC Mouthguard, Prescription
Cleared on Nov 20, 2012 as substantially equivalent to K053580 (Dental Concepts, LLC, 2006) and 2 other predicates after a 197-day review. Its family tree reaches back 2 generations to 1989. 4 later devices descend from it.
- Decided
- Nov 20, 2012
- Review
- 197 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K882303 (1989). 8 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 1 generation backK014079 DR. Hays Bite GuardInventive Resources, Inc. · 2002
- This deviceK121365 Thermoformed MouthguardsGlidewell Laboratories-Sleep Devices Group · 2012
- Descendant · cites it directly · 2 of its ownK210011 JS Dental Lab Mouth GuardAmpower Dental Laboratories, LLC · 2021
- Descendant · 2 generations on · 1 of its ownK241369 LIJIA Night GuardLijia, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK243516 Remi Custom Night GuardGrindguard, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK202465 Night Guard3D Diagnostix, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K210011JS Dental Lab Mouth GuardAmpower Dental Laboratories, LLC · 2021 · cites it directly2descendants
- K241369LIJIA Night GuardLijia, LLC · 2024 · 2 generations on1descendant
- K243516Remi Custom Night GuardGrindguard, Inc. · 2025 · 3 generations on0descendants
- K202465Night Guard3D Diagnostix, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −1 | K014079 | DR. Hays Bite Guard | Inventive Resources, Inc. | 2002 | — |
| 0 (this device) | K121365 | Thermoformed Mouthguards | Glidewell Laboratories-Sleep Devices Group | 2012 | — |
| +1 | K210011 | JS Dental Lab Mouth Guard | Ampower Dental Laboratories, LLC | 2021 | — |
| +2 | K241369 | LIJIA Night Guard | Lijia, LLC | 2024 | — |
| +3 | K243516 | Remi Custom Night Guard | Grindguard, Inc. | 2025 | — |
| +1 | K202465 | Night Guard | 3D Diagnostix, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K053580 | Doctor's NightguardSummary page 1…MQC Panel: Dental C. IDENTIFICATION OF PREDICATE DEVICE Trade/Proprietary Name: Doctor's® NightGuard TM (K053580), Ez Splint & Ez Splint PM (K022809) and Dr. Hays Bite Guard… | 2006 |
| * | K022809 | EZ Splint & EZ Splint PMSummary page 1…OF PREDICATE DEVICE Trade/Proprietary Name: Doctor's® NightGuard TM (K053580), Ez Splint & Ez Splint PM (K022809) and Dr. Hays Bite Guard (KO014079) D. DEVICE DESCRIPTION The Thermoform… | 2003 |
| * | K014079 | DR. Hays Bite GuardSummary page 4…rmed MouthguardsfNightguards are substantially equivalent to the Doctor's® NightGuar T (K053580), Ez Splint & Ez Splint PM (K022809) and Dr. Hays Bite Guard (K014079). These mouthguards/nightguards are substantially equivalent in intended use, indication for use, material, design and… | 2002 |
What descends from it? (4)
2 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 23 years and passes through 3 companies; a new generation was cleared every 12.9 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K210011 (Ampower Dental Laboratories, LLC, 2021) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K053580.
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Thermoformed Mouthguards are intended for
protection against bruxism and nighttime teeth grinding. They create a barrier
between the upper and lower dentition to protect the patient's overall occlusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121365 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121365: Thermoformed Mouthguards.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121365
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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