510(k) · Cleared
ClearedRest Assured Ready to Wear Nite Protector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ranir, LLC · OBR Mouthguard, Over-The-Counter
Cleared on Jan 27, 2012 as substantially equivalent to K091792 (Ranir Corporation, 2009) and 2 other predicates after a 119-day review. Its family tree reaches back 4 generations to 2003. 2 later devices descend from it.
- Decided
- Jan 27, 2012
- Review
- 119 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K022809 (2003). 17 ancestors in all, the oldest K882303 (1989). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK022809 EZ Splint & EZ Splint PMPower Products, Inc.-Splintek · 2003
- 3 generations backK072147 Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc. · 2007
- 2 generations backK082301 Grind NO MorePlacontrol, Inc. · 2008
- 1 generation backK091175 Grind NO More Version 2 and 3Ranir, LLC · 2009
- This deviceK112879 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
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 |
|---|---|---|---|---|---|
| −4 | K022809 | EZ Splint & EZ Splint PM | Power Products, Inc.-Splintek | 2003 | — |
| −3 | K072147 | Den Tek Comfort Fit Nightguard | Den Tek Oral Care, Inc. | 2007 | — |
| −2 | K082301 | Grind NO More | Placontrol, Inc. | 2008 | — |
| −1 | K091175 | Grind NO More Version 2 and 3 | Ranir, LLC | 2009 | — |
| 0 (this device) | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (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 1…tion Name Mouthguard, Over-the-Counter Classification Product Code OBR Predicate Devices Ranir, LLC's Rest Assured Generation 11 Dental Protector (K091792) Ranir, LLC's Grind No More Version 2 (K091 175) Splintek - Power Products Inc.'s SleepRight No Boil Dental Guard (K0… | 2009 |
| * | K091175 | Grind NO More Version 2 and 3Summary page 1…fication Product Code OBR Predicate Devices Ranir, LLC's Rest Assured Generation 11 Dental Protector (K091792) Ranir, LLC's Grind No More Version 2 (K091 175) Splintek - Power Products Inc.'s SleepRight No Boil Dental Guard (K07 1404) Purpose of the Special 510(k)… | 2009 |
| * | K071404 | Sleep Right - Select, Low Profile and AdvanceSummary page 1…ed Generation 11 Dental Protector (K091792) Ranir, LLC's Grind No More Version 2 (K091 175) Splintek - Power Products Inc.'s SleepRight No Boil Dental Guard (K07 1404) Purpose of the Special 510(k) notice The Rest Assured Ready to Wear Nite Protector is a modification to… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133423 | Rest Assured Extra Comfort Nite Protector | 2013 | 1 |
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 9 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K133423 (Ranir, LLC, 2013) has gone furthest, with 1 descendant of its own.
- 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. 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 Rest Assured Ready to Wear Nite 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/K112879 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112879: Rest Assured Ready to Wear Nite Protector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112879
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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