510(k) · Cleared
ClearedDentemp Pro-Comfort Dental Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Doc Brands, Inc. · OBR Mouthguard, Over-The-Counter
Cleared on May 19, 2025 as substantially equivalent to K091660 (Den Tek Oral Care, Inc., 2009) after a 90-day review. Its family tree reaches back 4 generations to 2006.
- Decided
- May 19, 2025
- Review
- 90 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K053580 (2006). No later device cites it as a predicate yet.
- Root · 4 generations backK053580 Doctor's NightguardDental Concepts, LLC · 2006
- 3 generations backK063483 Den Tek NightguardDen Tek Oral Care, Inc. · 2007
- 2 generations backK083400 Custom Comfort NightguardDen Tek Oral Care, Inc. · 2008
- 1 generation backK091660 Custom Comfort Nightguard Version 2Den Tek Oral Care, Inc. · 2009
- This deviceK250456 Dentemp Pro-Comfort Dental GuardDoc Brands, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K053580 | Doctor's Nightguard | Dental Concepts, LLC | 2006 | — |
| −3 | K063483 | Den Tek Nightguard | Den Tek Oral Care, Inc. | 2007 | — |
| −2 | K083400 | Custom Comfort Nightguard | Den Tek Oral Care, Inc. | 2008 | — |
| −1 | K091660 | Custom Comfort Nightguard Version 2 | Den Tek Oral Care, Inc. | 2009 | — |
| 0 (this device) | K250456 | Dentemp Pro-Comfort Dental Guard | Doc Brands, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K091660 | Custom Comfort Nightguard Version 2Summary page 5…vice Common Name: mouthguard, dental guard, nightguard Classification Name: Mouthguard, Over-the-Counter Product Code: OBR Regulation Number: Unclassified 510(k) Number: K091660 Reference Device Device Trade Name: Ora-GUARD Dental Grind Guard Applicant: Bite Tech Inc. Device Common Name: mouthguard, over… | 2009 |
| † | K150492 | Ora-GUARD Dental Grind Guard | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K091660.
How does its category compare?
All OBR devicesOBR Mouthguard, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Dentemp Pro-Comfort is indicated for protection against nighttime teeth grinding (bruxism). It is intended to reduce damage to teeth and prevent the noise associated with teeth grinding and bruxism.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250456 · printed Nov 5, 2026
Cite this page
510(k) Report. “K250456: Dentemp Pro-Comfort Dental Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K250456
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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