510(k) · Cleared
ClearedSmartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard Elite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smartguard, Inc. · MQC Mouthguard, Prescription
Cleared on Mar 14, 2013 as substantially equivalent to K071404 (Power Products, Inc.-Splintek, 2007) and 3 other predicates after a 156-day review. Its family tree reaches back 5 generations to 1989. 9 later devices descend from it.
- Decided
- Mar 14, 2013
- Review
- 156 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K882303 (1989). 16 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 4 generations backK014079 DR. Hays Bite GuardInventive Resources, Inc. · 2002
- 3 generations backK024261 Dental ProtectorDental Concepts, LLC · 2003
- 2 generations backK073220 The Doctor's Nightguard Advanced ComfortPrestige Brands, Inc. · 2007
- 1 generation backK082723 GrindguardGrind Guard Technologies, LLC · 2009
- This deviceK123161 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
- Descendant · 5 generations on · 0 of its ownK253641 Owl Night GuardOwl Dental Lab, Inc. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- 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
- K253641Owl Night GuardOwl Dental Lab, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −4 | K014079 | DR. Hays Bite Guard | Inventive Resources, Inc. | 2002 | — |
| −3 | K024261 | Dental Protector | Dental Concepts, LLC | 2003 | — |
| −2 | K073220 | The Doctor's Nightguard Advanced Comfort | Prestige Brands, Inc. | 2007 | — |
| −1 | K082723 | Grindguard | Grind Guard Technologies, LLC | 2009 | — |
| 0 (this device) | 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 | — |
| +5 | K253641 | Owl Night Guard | Owl Dental Lab, Inc. | 2026 | — |
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 |
|---|---|---|
| 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071404 | Sleep Right - Select, Low Profile and AdvanceSummary page 1…ental Guard/Night Guard/Mouth Guard Classification Name: Unclassified C. Predicate Devices: Sleepkight Products (K071404 and K(022809) (SleepRight- Select; SleepRight - Low Profile; SleepRight -… | 2007 |
| * | K022809 | EZ Splint & EZ Splint PMSummary page 1…ght Guard/Mouth Guard Classification Name: Unclassified C. Predicate Devices: Sleepkight Products (K071404 and K(022809) (SleepRight- Select; SleepRight - Low Profile; SleepRight -… | 2003 |
| * | K110468 | Freeway Comfort Bite GuardSummary page 1…n Suppression System (1(010876 & K98 1546) Freeway Comfort Bite Guard (K 110468) GrindGuardn (K082723) Brux-T… | 2011 |
| * | K082723 | GrindguardSummary page 1…K98 1546) Freeway Comfort Bite Guard (K 110468) GrindGuardn (K082723) Brux-TMD QuickSplint (KL 11066)… | 2009 |
| Kept off the family tree | K110066 | FDA’s K110066 is Aquilion Prime Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2012 |
What descends from it? (9)
3 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 24 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K133037 (Grind Guard Technologies, LLC, 2014) has gone furthest, with 6 descendants of its own.
- 8 other devices also cite its predicate K071404.
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
OTC: Protection against bruxism or night time teeth grinding Reduce damage to the teeth and reduce the noise associated with bruxing and/or grinding Rx: Protection of teeth grinding, bruxism, and jaw clenching. Protection of restorations from injury due to bruxism or clenching. Relief of bruxism related headaches and pains. Short-term pain relief from muscle spasm due to occlusal interference; for the prevention of chronic tension and temporal mandibular…
Read the full statement (104 words)
OTC:
Protection against bruxism or night time teeth grinding
Reduce damage to the teeth and reduce the noise associated with bruxing and/or grinding
Rx:
Protection of teeth grinding, bruxism, and jaw clenching.
Protection of restorations from injury due to bruxism or clenching.
Relief of bruxism related headaches and pains.
Short-term pain relief from muscle spasm due to occlusal interference; for the prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.
Temporary treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated headaches and pains.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123161: Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard Elite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123161
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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