510(k) · Cleared
ClearedCustMBite Dental Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dental Choice Holdings, LLC · OBR Mouthguard, Over-The-Counter
Cleared on Aug 23, 2019 as substantially equivalent to K113326 (Oralabs, Inc., 2012) after a 266-day review. Its family tree reaches back 4 generations to 2006.
- Decided
- Aug 23, 2019
- Review
- 266 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 backK113326 Oral B Plus Outlast Night Time Dental GuardOralabs, Inc. · 2012
- This deviceK183315 CustMBite Dental GuardDental Choice Holdings, LLC · 2019
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 | K113326 | Oral B Plus Outlast Night Time Dental Guard | Oralabs, Inc. | 2012 | — |
| 0 (this device) | K183315 | CustMBite Dental Guard | Dental Choice Holdings, LLC | 2019 | — |
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 |
|---|---|---|---|
| * | K113326 | Oral B Plus Outlast Night Time Dental GuardSummary page 4…Unclassified Predicate Device: Brand Name 510(k) Number Oral-B plus Scope Outlast Nighttime Dental Guard K113326 Device Description CustMbite Dental Guard is an over-the-counter dental protector, which is used as a barrier between teeth fo… | 2012 |
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 13 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K113326.
How does its category compare?
All OBR devicesOBR Mouthguard, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 CustMBite Dental Guard is an over-the-counter dental guard indicated for the protection against bruxism — 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 with teeth grinding.
The CustMBite Dental Guard is intended for individuals age 18 and older.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K183315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183315: CustMBite 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/K183315
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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