510(k) · Cleared
ClearedDen Tek Nightguard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Den Tek Oral Care, Inc. · MQC Mouthguard, Prescription
Cleared on Jan 23, 2007 as substantially equivalent to K053580 (Dental Concepts, LLC, 2006) after a 67-day review. Its family tree reaches back 1 generation to 2006. 31 later devices descend from it.
- Decided
- Jan 23, 2007
- Review
- 67 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053580 (2006). 31 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK053580 Doctor's NightguardDental Concepts, LLC · 2006
- This deviceK063483 Den Tek NightguardDen Tek Oral Care, Inc. · 2007
- Descendant · cites it directly · 19 of its ownK072147 Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc. · 2007
- Descendant · cites it directly · 10 of its ownK083400 Custom Comfort NightguardDen Tek Oral Care, Inc. · 2008
- Descendant · 2 generations on · 8 of its ownK082301 Grind NO MorePlacontrol, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK091660 Custom Comfort Nightguard Version 2Den Tek Oral Care, Inc. · 2009
- Descendant · 2 generations on · 5 of its ownK121272 Protech DentAkervall Technologies, Inc. · 2012
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K072147Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc. · 2007 · cites it directly19descendants
- K083400Custom Comfort NightguardDen Tek Oral Care, Inc. · 2008 · cites it directly10descendants
- K082301Grind NO MorePlacontrol, Inc. · 2008 · 2 generations on8descendants
- K091660Custom Comfort Nightguard Version 2Den Tek Oral Care, Inc. · 2009 · cites it directly6descendants
- K121272Protech DentAkervall Technologies, Inc. · 2012 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053580 | Doctor's Nightguard | Dental Concepts, LLC | 2006 | — |
| 0 (this device) | K063483 | Den Tek Nightguard | Den Tek Oral Care, Inc. | 2007 | — |
| +1 | K072147 | Den Tek Comfort Fit Nightguard | Den Tek Oral Care, Inc. | 2007 | — |
| +1 | K083400 | Custom Comfort Nightguard | Den Tek Oral Care, Inc. | 2008 | — |
| +2 | K082301 | Grind NO More | Placontrol, Inc. | 2008 | — |
| +1 | K091660 | Custom Comfort Nightguard Version 2 | Den Tek Oral Care, Inc. | 2009 | — |
| +2 | K121272 | Protech Dent | Akervall Technologies, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K053580 | Doctor's NightguardSummary page 1…simile: (865) 983-2444 Common or Usual Name Dental Protector Classification Name Unclassified Predicate Devices The Doctor's NightGuard (K053580) 16 \\ -C028322/000001 - 2393065 vi Intended Use / I… | 2006 |
What descends from it? (31)
See all 314 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?
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 DenTek NightGuard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or teeth grinding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063483 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063483: Den Tek Nightguard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063483
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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