510(k) · Cleared
ClearedGrindguard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grind Guard Technologies, LLC · OBR Mouthguard, Over-The-Counter
Cleared on Jan 23, 2014 as substantially equivalent to K082723 (Grind Guard Technologies, LLC, 2009) and 1 other predicate after a 119-day review. Its family tree reaches back 6 generations to 1989. 6 later devices descend from it.
- Decided
- Jan 23, 2014
- Review
- 119 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K882303 (1989). 17 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 5 generations backK014079 DR. Hays Bite GuardInventive Resources, Inc. · 2002
- 4 generations backK024261 Dental ProtectorDental Concepts, LLC · 2003
- 3 generations backK073220 The Doctor's Nightguard Advanced ComfortPrestige Brands, Inc. · 2007
- 2 generations backK082723 GrindguardGrind Guard Technologies, LLC · 2009
- 1 generation backK123161 Smartguard Night Guard, Smartguard Original, Smartguard Night Guard…Smartguard, Inc. · 2013
- This deviceK133037 GrindguardGrind Guard Technologies, LLC · 2014
- Descendant · cites it directly · 5 of its ownK181099 Bright GuardKoncept Innovators, LLC · 2019
- Descendant · 2 generations on · 3 of its ownK221369 FBCC Night GuardFbcc, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK251778 Remi Custom Night GuardRemi · 2025
- Descendant · 4 generations on · 0 of its ownK253641 Owl Night GuardOwl Dental Lab, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK252004 enCore Night GuardEncore Guards · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K181099Bright GuardKoncept Innovators, LLC · 2019 · cites it directly5descendants
- K221369FBCC Night GuardFbcc, Inc. · 2022 · 2 generations on3descendants
- K251778Remi Custom Night GuardRemi · 2025 · 3 generations on1descendant
- K253641Owl Night GuardOwl Dental Lab, Inc. · 2026 · 4 generations on0descendants
- K252004enCore Night GuardEncore Guards · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −5 | K014079 | DR. Hays Bite Guard | Inventive Resources, Inc. | 2002 | — |
| −4 | K024261 | Dental Protector | Dental Concepts, LLC | 2003 | — |
| −3 | K073220 | The Doctor's Nightguard Advanced Comfort | Prestige Brands, Inc. | 2007 | — |
| −2 | K082723 | Grindguard | Grind Guard Technologies, LLC | 2009 | — |
| −1 | K123161 | Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original… | Smartguard, Inc. | 2013 | — |
| 0 (this device) | K133037 | Grindguard | Grind Guard Technologies, LLC | 2014 | — |
| +1 | K181099 | Bright Guard | Koncept Innovators, LLC | 2019 | — |
| +2 | K221369 | FBCC Night Guard | Fbcc, Inc. | 2022 | — |
| +3 | K251778 | Remi Custom Night Guard | Remi | 2025 | — |
| +4 | K253641 | Owl Night Guard | Owl Dental Lab, Inc. | 2026 | — |
| +3 | K252004 | enCore Night Guard | Encore Guards | 2025 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K082723 | GrindguardSummary page 2…5 5.6 Legally Marketed Device To Which. The Device Is Substantially Equivalent Grindguard Technologies - GrindGuardN (RX)*- 1(082723 SmartGuard, Inc. - SmartGuard Night Guard - K123161 5.7 Description Of The Device The GrindcuadN is an oral appliance consis… | 2009 |
| * | K123161 | Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard…Summary page 2…Marketed Device To Which. The Device Is Substantially Equivalent Grindguard Technologies - GrindGuardN (RX)*- 1(082723 SmartGuard, Inc. - SmartGuard Night Guard - K123161 5.7 Description Of The Device The GrindcuadN is an oral appliance consisting of a thin exterior tray (shell) that covers app… | 2013 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181099 | Bright Guard | 2019 | 5 |
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 25 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K181099 (Koncept Innovators, LLC, 2019) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K082723.
How does its category compare?
All OBR devicesOBR Mouthguard, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 GrindGuardN is a mouth guard intended to protect against grinding and clenching.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133037 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133037: Grindguard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133037
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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