510(k) · Cleared
ClearedDen Tek Comfort Fit 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 Aug 30, 2007 as substantially equivalent to K063483 (Den Tek Oral Care, Inc., 2007) and 1 other predicate after a 27-day review. Its family tree reaches back 1 generation to 2003. 19 later devices descend from it.
- Decided
- Aug 30, 2007
- Review
- 27 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K022809 (2003). 5 ancestors in all, the oldest K010876 (2001). 19 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK022809 EZ Splint & EZ Splint PMPower Products, Inc.-Splintek · 2003
- This deviceK072147 Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc. · 2007
- Descendant · cites it directly · 8 of its ownK082301 Grind NO MorePlacontrol, Inc. · 2008
- Descendant · cites it directly · 5 of its ownK121272 Protech DentAkervall Technologies, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK091175 Grind NO More Version 2 and 3Ranir, LLC · 2009
- Descendant · 2 generations on · 3 of its ownK172223 SleepRight ProRx Custom Dental GuardSplintek, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK193577 SleepRight ProRx Custom Dental GuardSplintek, Inc. · 2020
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K082301Grind NO MorePlacontrol, Inc. · 2008 · cites it directly8descendants
- K121272Protech DentAkervall Technologies, Inc. · 2012 · cites it directly5descendants
- K091175Grind NO More Version 2 and 3Ranir, LLC · 2009 · cites it directly4descendants
- K172223SleepRight ProRx Custom Dental GuardSplintek, Inc. · 2017 · 2 generations on3descendants
- K193577SleepRight ProRx Custom Dental GuardSplintek, Inc. · 2020 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022809 | EZ Splint & EZ Splint PM | Power Products, Inc.-Splintek | 2003 | — |
| 0 (this device) | K072147 | Den Tek Comfort Fit Nightguard | Den Tek Oral Care, Inc. | 2007 | — |
| +1 | K082301 | Grind NO More | Placontrol, Inc. | 2008 | — |
| +1 | K121272 | Protech Dent | Akervall Technologies, Inc. | 2012 | — |
| +1 | K091175 | Grind NO More Version 2 and 3 | Ranir, LLC | 2009 | — |
| +2 | K172223 | SleepRight ProRx Custom Dental Guard | Splintek, Inc. | 2017 | — |
| +2 | K193577 | SleepRight ProRx Custom Dental Guard | Splintek, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (2)
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 1…) 983-2444 Common or Usual Name Nightguard Classification Name Unclassified Predicate Devices DenTek Oral Care, Inc.'s NightGuard (K063483) 32 \\\DC- 028322/000001 . 2581993 v4… | 2007 |
| * | K022809 | EZ Splint & EZ Splint PMSummary page 2…32 \\\DC- 028322/000001 . 2581993 v4 Power Product Inc.'s Splintek EZ-Splint (K022809) Purpose of the Special 510(k) Notice The Comfort Fit is a modification to the DenTek NightGuard. Intended Use… | 2003 |
What descends from it? (19)
See all 196 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 OBR devicesOBR Mouthguard, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 DenTek Comfort Fit 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/K072147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072147: Den Tek Comfort Fit Nightguard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072147
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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