510(k) · Cleared
ClearedRest Assured Generation II Dental Protector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ranir Corporation · OBR Mouthguard, Over-The-Counter
Cleared on Jul 8, 2009 as substantially equivalent to K063229 (Ranir, LLC, 2006) and 1 other predicate after a 21-day review. Its family tree reaches back 4 generations to 1989. 5 later devices descend from it.
- Decided
- Jul 8, 2009
- Review
- 21 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K882303 (1989). 11 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 3 generations backK014079 DR. Hays Bite GuardInventive Resources, Inc. · 2002
- 2 generations backK024261 Dental ProtectorDental Concepts, LLC · 2003
- 1 generation backK063229 Rest Assured Nite ProtectorRanir, LLC · 2006
- This deviceK091792 Rest Assured Generation II Dental ProtectorRanir Corporation · 2009
- Descendant · cites it directly · 2 of its ownK112879 Rest Assured Ready to Wear Nite ProtectorRanir, LLC · 2012
- Descendant · cites it directly · 1 of its ownK133423 Rest Assured Extra Comfort Nite ProtectorRanir, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK232238 Goyo Mouthpiece SDimedikorea · 2024
- Descendant · cites it directly · 0 of its ownK132469 The Bite GuardInternational Profit Builders, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK120103 Rest Assured Generation Iii Dental ProtectorRanir, LLC · 2012
Most influential descendants
Showing 5 of 5 · See all- K112879Rest Assured Ready to Wear Nite ProtectorRanir, LLC · 2012 · cites it directly2descendants
- K133423Rest Assured Extra Comfort Nite ProtectorRanir, LLC · 2013 · cites it directly1descendant
- K232238Goyo Mouthpiece SDimedikorea · 2024 · 2 generations on0descendants
- K132469The Bite GuardInternational Profit Builders, Inc. · 2014 · cites it directly0descendants
- K120103Rest Assured Generation Iii Dental ProtectorRanir, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −3 | K014079 | DR. Hays Bite Guard | Inventive Resources, Inc. | 2002 | — |
| −2 | K024261 | Dental Protector | Dental Concepts, LLC | 2003 | — |
| −1 | K063229 | Rest Assured Nite Protector | Ranir, LLC | 2006 | — |
| 0 (this device) | K091792 | Rest Assured Generation II Dental Protector | Ranir Corporation | 2009 | — |
| +1 | K112879 | Rest Assured Ready to Wear Nite Protector | Ranir, LLC | 2012 | — |
| +1 | K133423 | Rest Assured Extra Comfort Nite Protector | Ranir, LLC | 2013 | — |
| +2 | K232238 | Goyo Mouthpiece S | Dimedikorea | 2024 | — |
| +1 | K132469 | The Bite Guard | International Profit Builders, Inc. | 2014 | — |
| +1 | K120103 | Rest Assured Generation Iii Dental Protector | Ranir, LLC | 2012 | — |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K063229 | Rest Assured Nite ProtectorSummary page 2…ion Name Mouthguard, Over-the-Counter Classification Product Code OBR Predicate Devices Ranir, LLC's Rest Assured Night Protector (K063229) Prestige Brands, Inc.'s Doctor's Nightguard Advanced Comfort Fit (K073220) Purpose of the Special 510(k) notice.… | 2006 |
| * | K073220 | The Doctor's Nightguard Advanced ComfortSummary page 2…BR Predicate Devices Ranir, LLC's Rest Assured Night Protector (K063229) Prestige Brands, Inc.'s Doctor's Nightguard Advanced Comfort Fit (K073220) Purpose of the Special 510(k) notice. The Rest Assured Generation II is a modification to Ranir's Rest Assured Night Pr… | 2007 |
What descends from it? (5)
4 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 20 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K112879 (Ranir, LLC, 2012) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K063229.
How does its category compare?
All OBR devicesOBR Mouthguard, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Rest Assured Generation II Dental Protector is indicated for use for protection against bruxism or nighttime teeth grinding. The device 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/K091792 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091792: Rest Assured Generation II Dental Protector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091792
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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