510(k) · Cleared
ClearedDental Protector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dental Concepts, LLC · MQC Mouthguard, Prescription
Cleared on Mar 26, 2003 as substantially equivalent to K014079 (Inventive Resources, Inc., 2002) after a 93-day review. Its family tree reaches back 2 generations to 1989. 20 later devices descend from it.
- Decided
- Mar 26, 2003
- Review
- 93 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K882303 (1989). 4 ancestors in all. 20 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 deviceK024261 Dental ProtectorDental Concepts, LLC · 2003
- Descendant · cites it directly · 17 of its ownK073220 The Doctor's Nightguard Advanced ComfortPrestige Brands, Inc. · 2007
- Descendant · 2 generations on · 10 of its ownK082723 GrindguardGrind Guard Technologies, LLC · 2009
- Descendant · 3 generations on · 9 of its ownK123161 Smartguard Night Guard, Smartguard Original, Smartguard Night Guard…Smartguard, Inc. · 2013
- Descendant · cites it directly · 7 of its ownK063229 Rest Assured Nite ProtectorRanir, LLC · 2006
- Descendant · 3 generations on · 6 of its ownK133037 GrindguardGrind Guard Technologies, LLC · 2014
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K073220The Doctor's Nightguard Advanced ComfortPrestige Brands, Inc. · 2007 · cites it directly17descendants
- K082723GrindguardGrind Guard Technologies, LLC · 2009 · 2 generations on10descendants
- K123161Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard…Smartguard, Inc. · 2013 · 3 generations on9descendants
- K063229Rest Assured Nite ProtectorRanir, LLC · 2006 · cites it directly7descendants
- K133037GrindguardGrind Guard Technologies, LLC · 2014 · 3 generations on6descendants
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) | K024261 | Dental Protector | Dental Concepts, LLC | 2003 | — |
| +1 | K073220 | The Doctor's Nightguard Advanced Comfort | Prestige Brands, Inc. | 2007 | — |
| +2 | K082723 | Grindguard | Grind Guard Technologies, LLC | 2009 | — |
| +3 | K123161 | Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original… | Smartguard, Inc. | 2013 | — |
| +1 | K063229 | Rest Assured Nite Protector | Ranir, LLC | 2006 | — |
| +3 | K133037 | Grindguard | Grind Guard Technologies, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K014079 | DR. Hays Bite Guard | 2002 |
What descends from it? (20)
See all 202 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 14 years and passes through 3 companies; a new generation was cleared every 12.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K073220 (Prestige Brands, Inc., 2007) has gone furthest, with 17 descendants of its own.
- 4 other devices also cite its predicate K014079.
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 Dental Concepts Bite Plate is indicated for protection against bruxism (nighttime teeth grinding) and jaw clenching during sleep, short-term pain relief from muscle spasm due to occlusal interference, and prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the posterior mandibular and maxillary teeth by the temporalis muscle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024261: Dental Protector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024261
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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