510(k) · Cleared
ClearedDoctor's Nightguard
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 3, 2006 after a 71-day review. The FDA summary names its predicate without a number. 62 later devices descend from it.
- Decided
- Mar 3, 2006
- Review
- 71 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 0
62 later devices descend from it, 8 citing it directly.
- This deviceK053580 Doctor's NightguardDental Concepts, LLC · 2006
- Descendant · cites it directly · 31 of its ownK063483 Den Tek NightguardDen Tek Oral Care, Inc. · 2007
- Descendant · 2 generations on · 19 of its ownK072147 Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc. · 2007
- 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 · 2 generations on · 10 of its ownK083400 Custom Comfort NightguardDen Tek Oral Care, Inc. · 2008
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 62 · See all- K063483Den Tek NightguardDen Tek Oral Care, Inc. · 2007 · cites it directly31descendants
- K072147Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc. · 2007 · 2 generations on19descendants
- K073220The Doctor's Nightguard Advanced ComfortPrestige Brands, Inc. · 2007 · cites it directly17descendants
- K082723GrindguardGrind Guard Technologies, LLC · 2009 · 2 generations on10descendants
- K083400Custom Comfort NightguardDen Tek Oral Care, Inc. · 2008 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053580 | Doctor's Nightguard | Dental Concepts, LLC | 2006 | — |
| +1 | K063483 | Den Tek Nightguard | Den Tek Oral Care, Inc. | 2007 | — |
| +2 | K072147 | Den Tek Comfort Fit Nightguard | Den Tek Oral Care, Inc. | 2007 | — |
| +1 | K073220 | The Doctor's Nightguard Advanced Comfort | Prestige Brands, Inc. | 2007 | — |
| +2 | K082723 | Grindguard | Grind Guard Technologies, LLC | 2009 | — |
| +2 | K083400 | Custom Comfort Nightguard | Den Tek Oral Care, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 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 15.4 · 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 |
|---|---|---|---|
| * | — | Dental Concepts BruxGuard Named without a submission number | |
| * | — | Hollywood Products Mouth Peace Named without a submission number | |
| * | — | GEM Scientific Products, Inc. Tension Reliever Named without a submission number |
What descends from it? (62)
See all 628 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063483 | Den Tek Nightguard | 2007 | 31 |
| K073220 | The Doctor's Nightguard Advanced Comfort | 2007 | 17 |
| K063229 | Rest Assured Nite Protector | 2006 | 7 |
| K062828 | Mouthguard and Aligner Materials | 2006 | 6 |
| K121365 | Thermoformed Mouthguards | 2012 | 4 |
| K073446 | Grind Guard | 2008 | 2 |
| K072968 | Stressgard Nightguard | 2008 | 0 |
| K061122 | Night Guard | 2007 | 0 |
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, K063483 (Den Tek Oral Care, Inc., 2007) has gone furthest, with 31 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 Doctor's NightGuard is indicated for prottection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teoth and to prevent the noise associated with bruxing or grinding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053580 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053580: Doctor's Nightguard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053580
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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