510(k) · Cleared
ClearedLunaGuard Nighttime Dental Protector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mckeon Products · OBR Mouthguard, Over-The-Counter
Cleared on Aug 5, 2019 as substantially equivalent to K121272 (Akervall Technologies, Inc., 2012) after a 109-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Aug 5, 2019
- Review
- 109 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K022809 (2003). 7 ancestors in all, the oldest K010876 (2001). No later device cites it as a predicate yet.
- Root · 3 generations backK022809 EZ Splint & EZ Splint PMPower Products, Inc.-Splintek · 2003
- 2 generations backK072147 Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc. · 2007
- 1 generation backK121272 Protech DentAkervall Technologies, Inc. · 2012
- This deviceK191033 LunaGuard Nighttime Dental ProtectorMckeon Products · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K022809 | EZ Splint & EZ Splint PM | Power Products, Inc.-Splintek | 2003 | — |
| −2 | K072147 | Den Tek Comfort Fit Nightguard | Den Tek Oral Care, Inc. | 2007 | — |
| −1 | K121272 | Protech Dent | Akervall Technologies, Inc. | 2012 | — |
| 0 (this device) | K191033 | LunaGuard Nighttime Dental Protector | Mckeon Products | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K121272 | Protech DentSummary page 4…II Product Code: OBR 5.3 Equivalence Claimed to Predicate Device The LunaGuard™ Nighttime Dental Protector is equivalent to the Pro Tech Dent (K121272), manufactured by Akervall Technologies Inc.. 5.4 Device Description The LunaGuard™ Nighttime Dental Protector is an overthec… | 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 16 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K121272.
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 LunaGuard™ Nighttime Dental Protector is indicated for use in protecting the teeth and reducing damage caused by bruxism or nighttime grinding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191033 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191033: LunaGuard Nighttime Dental Protector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191033
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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