510(k) · Cleared
ClearedBright Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koncept Innovators, LLC · OBR Mouthguard, Over-The-Counter
Cleared on Jan 18, 2019 as substantially equivalent to K133037 (Grind Guard Technologies, LLC, 2014) after a 267-day review. Its family tree reaches back 7 generations to 1989. 5 later devices descend from it.
- Decided
- Jan 18, 2019
- Review
- 267 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K882303 (1989). 18 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 6 generations backK014079 DR. Hays Bite GuardInventive Resources, Inc. · 2002
- 5 generations backK024261 Dental ProtectorDental Concepts, LLC · 2003
- 4 generations backK073220 The Doctor's Nightguard Advanced ComfortPrestige Brands, Inc. · 2007
- 3 generations backK082723 GrindguardGrind Guard Technologies, LLC · 2009
- 2 generations backK123161 Smartguard Night Guard, Smartguard Original, Smartguard Night Guard…Smartguard, Inc. · 2013
- 1 generation backK133037 GrindguardGrind Guard Technologies, LLC · 2014
- This deviceK181099 Bright GuardKoncept Innovators, LLC · 2019
- Descendant · cites it directly · 3 of its ownK221369 FBCC Night GuardFbcc, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK251778 Remi Custom Night GuardRemi · 2025
- Descendant · 3 generations on · 0 of its ownK253641 Owl Night GuardOwl Dental Lab, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK252004 enCore Night GuardEncore Guards · 2025
- Descendant · cites it directly · 0 of its ownK240810 Anti Grinding GuardXiamen Yizhou Imp. & Exp. Co., Ltd. · 2024
Most influential descendants
Showing 5 of 5 · See all- K221369FBCC Night GuardFbcc, Inc. · 2022 · cites it directly3descendants
- K251778Remi Custom Night GuardRemi · 2025 · 2 generations on1descendant
- K253641Owl Night GuardOwl Dental Lab, Inc. · 2026 · 3 generations on0descendants
- K252004enCore Night GuardEncore Guards · 2025 · 2 generations on0descendants
- K240810Anti Grinding GuardXiamen Yizhou Imp. & Exp. Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −6 | K014079 | DR. Hays Bite Guard | Inventive Resources, Inc. | 2002 | — |
| −5 | K024261 | Dental Protector | Dental Concepts, LLC | 2003 | — |
| −4 | K073220 | The Doctor's Nightguard Advanced Comfort | Prestige Brands, Inc. | 2007 | — |
| −3 | K082723 | Grindguard | Grind Guard Technologies, LLC | 2009 | — |
| −2 | K123161 | Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original… | Smartguard, Inc. | 2013 | — |
| −1 | K133037 | Grindguard | Grind Guard Technologies, LLC | 2014 | — |
| 0 (this device) | K181099 | Bright Guard | Koncept Innovators, LLC | 2019 | — |
| +1 | K221369 | FBCC Night Guard | Fbcc, Inc. | 2022 | — |
| +2 | K251778 | Remi Custom Night Guard | Remi | 2025 | — |
| +3 | K253641 | Owl Night Guard | Owl Dental Lab, Inc. | 2026 | — |
| +2 | K252004 | enCore Night Guard | Encore Guards | 2025 | — |
| +1 | K240810 | Anti Grinding Guard | Xiamen Yizhou Imp. & Exp. Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K133037 | GrindguardSummary page 4…roduct Code: OBR Trade/Proprietary Name: Bright Guard Common Name: Mouth Guard 5. Primary Predicate Device: GrindGuardN, K133037; Reference Device: Rest Assured Extra Comfort Nite Protector Dental Protector, K133423. 6. Device Description Bright Guard is… | 2014 |
| † | K133423 | Rest Assured Extra Comfort Nite Protector | 2013 |
What descends from it? (5)
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 30 years and passes through 7 companies; a new generation was cleared every 3.5 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K221369 (Fbcc, Inc., 2022) has gone furthest, with 3 descendants of its own.
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?
Bright Guard is a mouth guard intended to protect against grinding and clenching.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181099 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181099: Bright Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181099
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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