510(k) · Cleared
ClearedRest Assured 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 Dec 19, 2006 as substantially equivalent to K053580 (Dental Concepts, LLC, 2006) and 3 other predicates after a 55-day review. Its family tree reaches back 3 generations to 1989. 7 later devices descend from it.
- Decided
- Dec 19, 2006
- Review
- 55 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K882303 (1989). 9 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 2 generations backK014079 DR. Hays Bite GuardInventive Resources, Inc. · 2002
- 1 generation backK024261 Dental ProtectorDental Concepts, LLC · 2003
- This deviceK063229 Rest Assured Nite ProtectorRanir, LLC · 2006
- Descendant · cites it directly · 5 of its ownK091792 Rest Assured Generation II Dental ProtectorRanir Corporation · 2009
- Descendant · 2 generations on · 2 of its ownK112879 Rest Assured Ready to Wear Nite ProtectorRanir, LLC · 2012
- Descendant · 2 generations on · 1 of its ownK133423 Rest Assured Extra Comfort Nite ProtectorRanir, LLC · 2013
- Descendant · 3 generations on · 0 of its ownK232238 Goyo Mouthpiece SDimedikorea · 2024
- Descendant · 2 generations on · 0 of its ownK132469 The Bite GuardInternational Profit Builders, Inc. · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K091792Rest Assured Generation II Dental ProtectorRanir Corporation · 2009 · cites it directly5descendants
- K112879Rest Assured Ready to Wear Nite ProtectorRanir, LLC · 2012 · 2 generations on2descendants
- K133423Rest Assured Extra Comfort Nite ProtectorRanir, LLC · 2013 · 2 generations on1descendant
- K232238Goyo Mouthpiece SDimedikorea · 2024 · 3 generations on0descendants
- K132469The Bite GuardInternational Profit Builders, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −2 | K014079 | DR. Hays Bite Guard | Inventive Resources, Inc. | 2002 | — |
| −1 | K024261 | Dental Protector | Dental Concepts, LLC | 2003 | — |
| 0 (this device) | K063229 | Rest Assured Nite Protector | Ranir, LLC | 2006 | — |
| +1 | K091792 | Rest Assured Generation II Dental Protector | Ranir Corporation | 2009 | — |
| +2 | K112879 | Rest Assured Ready to Wear Nite Protector | Ranir, LLC | 2012 | — |
| +2 | K133423 | Rest Assured Extra Comfort Nite Protector | Ranir, LLC | 2013 | — |
| +3 | K232238 | Goyo Mouthpiece S | Dimedikorea | 2024 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K053580 | Doctor's NightguardSummary page 2…the Device Rest Assured™ Nite Protector Common or Usual Name Dental Protector/Dental Mouthguard Classification Name Unclassified 6. Predicate Devices K053580, Dental Concepts LLC, Doctors® Night Guard™ K024261, Dental Concepts LLC, Bite Plate K014079, Inventive Resources, Inc., Dr. Hay… | 2006 |
| * | K024261 | Dental ProtectorSummary page 2…sual Name Dental Protector/Dental Mouthguard Classification Name Unclassified 6. Predicate Devices K053580, Dental Concepts LLC, Doctors® Night Guard™ K024261, Dental Concepts LLC, Bite Plate K014079, Inventive Resources, Inc., Dr. Hayes Bite Guard K022809, Power Products, Inc.-Splintek… | 2003 |
| * | K014079 | DR. Hays Bite GuardSummary page 2…ard Classification Name Unclassified 6. Predicate Devices K053580, Dental Concepts LLC, Doctors® Night Guard™ K024261, Dental Concepts LLC, Bite Plate K014079, Inventive Resources, Inc., Dr. Hayes Bite Guard K022809, Power Products, Inc.-Splintek, EZ Splint 7. Intended Use The Rest Ass… | 2002 |
| * | K022809 | EZ Splint & EZ Splint PMSummary page 2…Predicate Devices K053580, Dental Concepts LLC, Doctors® Night Guard™ K024261, Dental Concepts LLC, Bite Plate K014079, Inventive Resources, Inc., Dr. Hayes Bite Guard K022809, Power Products, Inc.-Splintek, EZ Splint 7. Intended Use The Rest Assured™ Nite Protector is indicated for protection against… | 2003 |
What descends from it? (7)
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 17 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K091792 (Ranir Corporation, 2009) has gone furthest, with 5 descendants of its own.
- 7 other devices also cite its predicate K053580.
How does its category compare?
All OBR devicesOBR Mouthguard, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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™ Nite Protector is indicated for protection against bruxism or
night time teeth grinding. The device is intended to reduce damage to teeth and prevent
noise associated with bruxing or grinding.
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/K063229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063229: Rest Assured 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/K063229
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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