510(k) · Cleared
ClearedEZ Splint & EZ Splint PM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Power Products, Inc.-Splintek · MQC Mouthguard, Prescription
Cleared on Oct 17, 2003 as substantially equivalent to DEN100024 (unknown applicant, ) and 1 other predicate after a 420-day review. 46 later devices descend from it.
- Decided
- Oct 17, 2003
- Review
- 420 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 2
2 ancestors in all, the oldest K010876 (2001). 46 later devices descend from it, 6 citing it directly.
- This deviceK022809 EZ Splint & EZ Splint PMPower Products, Inc.-Splintek · 2003
- Descendant · cites it directly · 19 of its ownK072147 Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc. · 2007
- Descendant · cites it directly · 9 of its ownK123161 Smartguard Night Guard, Smartguard Original, Smartguard Night Guard…Smartguard, Inc. · 2013
- Descendant · 2 generations on · 8 of its ownK082301 Grind NO MorePlacontrol, Inc. · 2008
- Descendant · cites it directly · 7 of its ownK063229 Rest Assured Nite ProtectorRanir, LLC · 2006
- Descendant · 2 generations on · 6 of its ownK133037 GrindguardGrind Guard Technologies, LLC · 2014
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K072147Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc. · 2007 · cites it directly19descendants
- K123161Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard…Smartguard, Inc. · 2013 · cites it directly9descendants
- K082301Grind NO MorePlacontrol, Inc. · 2008 · 2 generations on8descendants
- K063229Rest Assured Nite ProtectorRanir, LLC · 2006 · cites it directly7descendants
- K133037GrindguardGrind Guard Technologies, LLC · 2014 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022809 | EZ Splint & EZ Splint PM | Power Products, Inc.-Splintek | 2003 | — |
| +1 | K072147 | Den Tek Comfort Fit Nightguard | Den Tek Oral Care, Inc. | 2007 | — |
| +1 | K123161 | Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original… | Smartguard, Inc. | 2013 | — |
| +2 | K082301 | Grind NO More | Placontrol, Inc. | 2008 | — |
| +1 | K063229 | Rest Assured Nite Protector | Ranir, LLC | 2006 | — |
| +2 | K133037 | Grindguard | Grind Guard Technologies, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 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? (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 |
|---|---|---|---|
| * | DEN100024 | Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch Our reading of the summary gave K104029, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN100024, Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch (), granted —; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | |
| * | K010876 | Nti Tension Suppression System | 2001 |
What descends from it? (46)
See all 466 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072147 | Den Tek Comfort Fit Nightguard | 2007 | 19 |
| K123161 | Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard… | 2013 | 9 |
| K063229 | Rest Assured Nite Protector | 2006 | 7 |
| K062828 | Mouthguard and Aligner Materials | 2006 | 6 |
| K121365 | Thermoformed Mouthguards | 2012 | 4 |
| K061122 | Night Guard | 2007 | 0 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K072147 (Den Tek Oral Care, Inc., 2007) has gone furthest, with 19 descendants of its own.
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Protection against teeth grinding, bruxism and jaw clenching.
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 posterior mandibular and maxillary teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022809 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022809: EZ Splint & EZ Splint PM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022809
Report an extraction error
Are you the manufacturer?
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