510(k) · Cleared
ClearedThe Bite Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Profit Builders, Inc. · OBR Mouthguard, Over-The-Counter
Cleared on Feb 28, 2014 as substantially equivalent to K091792 (Ranir Corporation, 2009) and 2 other predicates after a 205-day review. Its family tree reaches back 5 generations to 1989.
- Decided
- Feb 28, 2014
- Review
- 205 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K882303 (1989). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 4 generations backK014079 DR. Hays Bite GuardInventive Resources, Inc. · 2002
- 3 generations backK024261 Dental ProtectorDental Concepts, LLC · 2003
- 2 generations backK063229 Rest Assured Nite ProtectorRanir, LLC · 2006
- 1 generation backK091792 Rest Assured Generation II Dental ProtectorRanir Corporation · 2009
- This deviceK132469 The Bite GuardInternational Profit Builders, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −4 | K014079 | DR. Hays Bite Guard | Inventive Resources, Inc. | 2002 | — |
| −3 | K024261 | Dental Protector | Dental Concepts, LLC | 2003 | — |
| −2 | K063229 | Rest Assured Nite Protector | Ranir, LLC | 2006 | — |
| −1 | K091792 | Rest Assured Generation II Dental Protector | Ranir Corporation | 2009 | — |
| 0 (this device) | K132469 | The Bite Guard | International Profit Builders, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2012 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K091792 | Rest Assured Generation II Dental ProtectorSummary page 4…equivalent in safety and effectiveness to Dentek's Custom Fit Night guard (K072147) and Oral B plus Outlast Nighttime Dental Guard (K1 13326). Ranir LLC's Rest Assured (K091792). 181 P age… | 2009 |
| * | K072147 | Den Tek Comfort Fit NightguardSummary page 2…st Comarion TheBit Gurd"Night guard Nighttime Dental Guard 510 (k) -Number K1 32469 K072147 K113326 Flexible, moldable Flexible, moldable… | 2007 |
| * | K113326 | Oral B Plus Outlast Night Time Dental GuardSummary page 2…ht guard Nighttime Dental Guard 510 (k) -Number K1 32469 K072147 K113326 Flexible, moldable Flexible, moldable mouth guard used as a mouth guard used… | 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 25 years and passes through 6 companies; a new generation was cleared every 3.7 years on median.
- None of the 16 ancestors has a recall.
- 3 other devices also cite its predicate K091792.
How does its category compare?
All OBR devicesOBR Mouthguard, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Bite Guard is used to prevent grinding of the teeth, jaw clenching and to reduce damage to the teeth from grinding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132469 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132469: The Bite Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132469
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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