510(k) · Cleared
ClearedOral B Plus Outlast Night Time Dental Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oralabs, Inc. · OBR Mouthguard, Over-The-Counter
Cleared on Jun 27, 2012 as substantially equivalent to K083400 (Den Tek Oral Care, Inc., 2008) after a 230-day review. Its family tree reaches back 3 generations to 2006. 2 later devices descend from it.
- Decided
- Jun 27, 2012
- Review
- 230 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K053580 (2006). 2 later devices descend from it, 2 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 deviceK113326 Oral B Plus Outlast Night Time Dental GuardOralabs, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK183315 CustMBite Dental GuardDental Choice Holdings, LLC · 2019
- Descendant · cites it directly · 0 of its ownK132469 The Bite GuardInternational Profit Builders, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView 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) | K113326 | Oral B Plus Outlast Night Time Dental Guard | Oralabs, Inc. | 2012 | — |
| +1 | K183315 | CustMBite Dental Guard | Dental Choice Holdings, LLC | 2019 | — |
| +1 | K132469 | The Bite Guard | International Profit Builders, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K083400 | Custom Comfort NightguardSummary page 1…ssified this device. 4. Devices to Which Substantial Equivalence is Claimed: OraLabs claims equivalence to Dentek's Custom Comfort Dental Guard, 510(k) Number K083400. Dentek Oral Care, Inc. I 307 Excellence Way Ma… | 2008 |
What descends from it? (2)
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 6 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K183315 (Dental Choice Holdings, LLC, 2019) has gone furthest, with 0 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. 2012, 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 Oral B plus Scope Outlast Nighttime Dental Guard is an Over-the-Counter dental guard indicated for the protection against bruxisin - the nighttime clenching and grinding of the teeth.
It is intended for use in the mouth at night to reduce damage to the teeth and to prevent the noise associated teeth grinding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113326: Oral B Plus Outlast Night Time Dental Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113326
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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