510(k) · Cleared
ClearedCustom Comfort Nightguard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Den Tek Oral Care, Inc. · OBR Mouthguard, Over-The-Counter
Cleared on Dec 11, 2008 as substantially equivalent to K063483 (Den Tek Oral Care, Inc., 2007) after a 24-day review. Its family tree reaches back 2 generations to 2006. 10 later devices descend from it.
- Decided
- Dec 11, 2008
- Review
- 24 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K053580 (2006). 10 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK053580 Doctor's NightguardDental Concepts, LLC · 2006
- 1 generation backK063483 Den Tek NightguardDen Tek Oral Care, Inc. · 2007
- This deviceK083400 Custom Comfort NightguardDen Tek Oral Care, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK091660 Custom Comfort Nightguard Version 2Den Tek Oral Care, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK180933 DenTek Ultimate Dental GuardMedtech Products, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK113326 Oral B Plus Outlast Night Time Dental GuardOralabs, Inc. · 2012
- Descendant · 3 generations on · 1 of its ownK231865 Mouth Guard (ATG0603R)Reazeal Corp · 2023
- Descendant · 4 generations on · 0 of its ownK252485 ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large…1987 Media Limited · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K091660Custom Comfort Nightguard Version 2Den Tek Oral Care, Inc. · 2009 · cites it directly6descendants
- K180933DenTek Ultimate Dental GuardMedtech Products, Inc. · 2018 · 2 generations on2descendants
- K113326Oral B Plus Outlast Night Time Dental GuardOralabs, Inc. · 2012 · cites it directly2descendants
- K231865Mouth Guard (ATG0603R)Reazeal Corp · 2023 · 3 generations on1descendant
- K252485ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore…1987 Media Limited · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K053580 | Doctor's Nightguard | Dental Concepts, LLC | 2006 | — |
| −1 | K063483 | Den Tek Nightguard | Den Tek Oral Care, Inc. | 2007 | — |
| 0 (this device) | K083400 | Custom Comfort Nightguard | Den Tek Oral Care, Inc. | 2008 | — |
| +1 | K091660 | Custom Comfort Nightguard Version 2 | Den Tek Oral Care, Inc. | 2009 | — |
| +2 | K180933 | DenTek Ultimate Dental Guard | Medtech Products, Inc. | 2018 | — |
| +1 | K113326 | Oral B Plus Outlast Night Time Dental Guard | Oralabs, Inc. | 2012 | — |
| +3 | K231865 | Mouth Guard (ATG0603R) | Reazeal Corp | 2023 | — |
| +4 | K252485 | ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size))… | 1987 Media Limited | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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 OBR? 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 OBR device
- #1 K251778 Remi Custom Night Guardscore 15.6 · 9 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 |
|---|---|---|---|
| * | K063483 | Den Tek NightguardSummary page 2…ication Name Mouthguard, Over-the-Counter Classification Product Code OBR Predicate Devices DenTek Oral Care Inc.'s DenTek Nightguard (K063483) Purpose of the Special 510(k) notice. The Custom Comfort Nightguard is a modification to DenTek Oral Care Inc.'s Den… | 2007 |
What descends from it? (10)
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 2 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K091660 (Den Tek Oral Care, Inc., 2009) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K063483.
How does its category compare?
All OBR devicesOBR Mouthguard, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · OBR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBR
129in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBR
No recall names OBR since 2007.
Adverse event reports per year · OBR
13in 2025
MAUDE reports naming product code OBR, 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 | 2 | — | 0 | 1 |
| 2008 | 5 | 55 | 0 | 0 |
| 2009 | 3 | 16 | 0 | 7 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 4 | 145 | 0 | 4 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 2 | — | 0 | 776 |
| 2015 | 1 | — | 0 | 31 |
| 2016 | 1 | — | 0 | 16 |
| 2017 | 1 | — | 0 | 24 |
| 2018 | 2 | — | 0 | 23 |
| 2019 | 3 | 266 | 0 | 29 |
| 2020 | 3 | 161 | 0 | 15 |
| 2021 | 2 | — | 0 | 10 |
| 2022 | 2 | — | 0 | 6 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 2 | — | 0 | 18 |
| 2025 | 3 | 129 | 0 | 13 |
| 2026 | 4 | 103 | 0 | — |
What is it indicated for?
The Custom Comfort Nightguard is indicated for use 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 grinding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083400 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083400: Custom Comfort Nightguard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083400
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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