510(k) · Cleared
ClearedCustom Comfort Nightguard Version 2
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 Jun 12, 2009 as substantially equivalent to K083400 (Den Tek Oral Care, Inc., 2008) and 1 other predicate after a 3-day review. Its family tree reaches back 3 generations to 2006. 6 later devices descend from it.
- Decided
- Jun 12, 2009
- Review
- 3 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K053580 (2006). 6 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK053580 Doctor's NightguardDental Concepts, LLC · 2006
- 2 generations backK063483 Den Tek NightguardDen Tek Oral Care, Inc. · 2007
- 1 generation backK083400 Custom Comfort NightguardDen Tek Oral Care, Inc. · 2008
- This deviceK091660 Custom Comfort Nightguard Version 2Den Tek Oral Care, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK180933 DenTek Ultimate Dental GuardMedtech Products, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK231865 Mouth Guard (ATG0603R)Reazeal Corp · 2023
- Descendant · 3 generations on · 0 of its ownK252485 ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large…1987 Media Limited · 2026
- Descendant · cites it directly · 0 of its ownK250456 Dentemp Pro-Comfort Dental GuardDoc Brands, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK172452 BruxorSleep Specialties, LLC · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K180933DenTek Ultimate Dental GuardMedtech Products, Inc. · 2018 · cites it directly2descendants
- K231865Mouth Guard (ATG0603R)Reazeal Corp · 2023 · 2 generations on1descendant
- K252485ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore…1987 Media Limited · 2026 · 3 generations on0descendants
- K250456Dentemp Pro-Comfort Dental GuardDoc Brands, Inc. · 2025 · cites it directly0descendants
- K172452BruxorSleep Specialties, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K053580 | Doctor's Nightguard | Dental Concepts, LLC | 2006 | — |
| −2 | K063483 | Den Tek Nightguard | Den Tek Oral Care, Inc. | 2007 | — |
| −1 | K083400 | Custom Comfort Nightguard | Den Tek Oral Care, Inc. | 2008 | — |
| 0 (this device) | K091660 | Custom Comfort Nightguard Version 2 | Den Tek Oral Care, Inc. | 2009 | — |
| +1 | K180933 | DenTek Ultimate Dental Guard | Medtech Products, Inc. | 2018 | — |
| +2 | K231865 | Mouth Guard (ATG0603R) | Reazeal Corp | 2023 | — |
| +3 | K252485 | ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size))… | 1987 Media Limited | 2026 | — |
| +1 | K250456 | Dentemp Pro-Comfort Dental Guard | Doc Brands, Inc. | 2025 | — |
| +1 | K172452 | Bruxor | Sleep Specialties, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083400 | Custom Comfort NightguardSummary page 1…sification Name Mouthguard, Over-the-Counter Classification Product Code OBR Predicate Devices DenTek Oral Care Inc.'s Custom Comfort Nightguard (K083400) DenTek Oral Care Inc.'s DenTek NightGuard (K063483) Dental Concepts, LLC's The Doctor's Nightguard Advanced Comfort… | 2008 |
| * | K063483 | Den Tek NightguardSummary page 1…ification Product Code OBR Predicate Devices DenTek Oral Care Inc.'s Custom Comfort Nightguard (K083400) DenTek Oral Care Inc.'s DenTek NightGuard (K063483) Dental Concepts, LLC's The Doctor's Nightguard Advanced Comfort (K1073 220) Purpose of the Special 510(k)… | 2007 |
| Kept off the family tree | K1073220 | The Doctor's Nightguard Advanced Comfort Number could not be read Summary page 1…c.'s Custom Comfort Nightguard (K083400) DenTek Oral Care Inc.'s DenTek NightGuard (K063483) Dental Concepts, LLC's The Doctor's Nightguard Advanced Comfort (K1073 220) Purpose of the Special 510(k) notice. The Custom Comfort Nightguard Version 2 is a modification to DenTe… |
What descends from it? (6)
4 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 3 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K180933 (Medtech Products, Inc., 2018) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K083400.
How does its category compare?
All OBR devicesOBR Mouthguard, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Version 2 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/K091660 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091660: Custom Comfort Nightguard Version 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091660
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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