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 · MQC Mouthguard, Prescription
Cleared on Aug 31, 2009 as substantially equivalent to K073220 (Prestige Brands, Inc., 2007) and 3 other predicates after a 348-day review. Its family tree reaches back 4 generations to 1989. 10 later devices descend from it.
- Decided
- Aug 31, 2009
- Review
- 348 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K882303 (1989). 11 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 3 generations backK014079 DR. Hays Bite GuardInventive Resources, Inc. · 2002
- 2 generations backK024261 Dental ProtectorDental Concepts, LLC · 2003
- 1 generation backK073220 The Doctor's Nightguard Advanced ComfortPrestige Brands, Inc. · 2007
- This deviceK082723 GrindguardGrind Guard Technologies, LLC · 2009
- Descendant · cites it directly · 9 of its ownK123161 Smartguard Night Guard, Smartguard Original, Smartguard Night Guard…Smartguard, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK133037 GrindguardGrind Guard Technologies, LLC · 2014
- Descendant · 2 generations on · 5 of its ownK181099 Bright GuardKoncept Innovators, LLC · 2019
- Descendant · 3 generations on · 3 of its ownK221369 FBCC Night GuardFbcc, Inc. · 2022
- Descendant · 4 generations on · 1 of its ownK251778 Remi Custom Night GuardRemi · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K123161Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard…Smartguard, Inc. · 2013 · cites it directly9descendants
- K133037GrindguardGrind Guard Technologies, LLC · 2014 · cites it directly6descendants
- K181099Bright GuardKoncept Innovators, LLC · 2019 · 2 generations on5descendants
- K221369FBCC Night GuardFbcc, Inc. · 2022 · 3 generations on3descendants
- K251778Remi Custom Night GuardRemi · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −3 | K014079 | DR. Hays Bite Guard | Inventive Resources, Inc. | 2002 | — |
| −2 | K024261 | Dental Protector | Dental Concepts, LLC | 2003 | — |
| −1 | K073220 | The Doctor's Nightguard Advanced Comfort | Prestige Brands, Inc. | 2007 | — |
| 0 (this device) | K082723 | Grindguard | Grind Guard Technologies, LLC | 2009 | — |
| +1 | K123161 | Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original… | Smartguard, Inc. | 2013 | — |
| +1 | K133037 | Grindguard | Grind Guard Technologies, LLC | 2014 | — |
| +2 | K181099 | Bright Guard | Koncept Innovators, LLC | 2019 | — |
| +3 | K221369 | FBCC Night Guard | Fbcc, Inc. | 2022 | — |
| +4 | K251778 | Remi Custom Night Guard | Remi | 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 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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 MQC? 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 MQC device
- #1 K203000 KeyPrint KeySplint Hardscore 15.3 · 5 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 |
|---|---|---|---|
| * | K073220 | The Doctor's Nightguard Advanced ComfortSummary page 1…ion Classification Code MQC Predicate Devices Substantial equivalence is being claimed to: * The Doctor's Nightguard Advanced Comfort (K073220) * NTI Tension Suppression System (K010876) · TAP- anti-snoring device (formerly Quiet Knight) (K962516) * Temporary Crown Matrix… | 2007 |
| * | K010876 | Nti Tension Suppression SystemSummary page 1…MQC Predicate Devices Substantial equivalence is being claimed to: * The Doctor's Nightguard Advanced Comfort (K073220) * NTI Tension Suppression System (K010876) · TAP- anti-snoring device (formerly Quiet Knight) (K962516) * Temporary Crown Matrix Buttons (K900389) Description of Device T… | 2001 |
| * | K962516 | Tap Anti-Snoring DeviceSummary page 1…is being claimed to: * The Doctor's Nightguard Advanced Comfort (K073220) * NTI Tension Suppression System (K010876) · TAP- anti-snoring device (formerly Quiet Knight) (K962516) * Temporary Crown Matrix Buttons (K900389) Description of Device The GrinGUARDN is an oral appliance consisting of a rigid oute… | 1996 |
| * | K900389 | Temporary Crown Matrix ButtonsSummary page 1…uard Advanced Comfort (K073220) * NTI Tension Suppression System (K010876) · TAP- anti-snoring device (formerly Quiet Knight) (K962516) * Temporary Crown Matrix Buttons (K900389) Description of Device The GrinGUARDN is an oral appliance consisting of a rigid outer tray with a dome shape protrusion in the… | 1990 |
What descends from it? (10)
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 20 years and passes through 5 companies; a new generation was cleared every 4.7 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K123161 (Smartguard, Inc., 2013) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K073220.
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MQC
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQC
185in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQC
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQC
7in 2025
MAUDE reports naming product code MQC, 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 | 4 | 79 | 0 | 9 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 4 | 194 | 0 | 2 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 3 | 234 | 0 | 5 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 2 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 71 |
| 2019 | 5 | 286 | 0 | 62 |
| 2020 | 4 | 204 | 0 | 46 |
| 2021 | 7 | 158 | 0 | 111 |
| 2022 | 5 | 120 | 0 | 137 |
| 2023 | 6 | 230 | 1 | 62 |
| 2024 | 8 | 249 | 0 | 8 |
| 2025 | 4 | 185 | 0 | 7 |
| 2026 | 2 | — | 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/K082723 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082723: Grindguard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082723
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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