510(k) · Cleared
ClearedGoyo Mouthpiece S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dimedikorea · OBR Mouthguard, Over-The-Counter
Cleared on Apr 17, 2024 as substantially equivalent to K133423 (Ranir, LLC, 2013) after a 264-day review. Its family tree reaches back 6 generations to 2003.
- Decided
- Apr 17, 2024
- Review
- 264 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K022809 (2003). 19 ancestors in all, the oldest K882303 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK022809 EZ Splint & EZ Splint PMPower Products, Inc.-Splintek · 2003
- 5 generations backK072147 Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc. · 2007
- 4 generations backK082301 Grind NO MorePlacontrol, Inc. · 2008
- 3 generations backK091175 Grind NO More Version 2 and 3Ranir, LLC · 2009
- 2 generations backK112879 Rest Assured Ready to Wear Nite ProtectorRanir, LLC · 2012
- 1 generation backK133423 Rest Assured Extra Comfort Nite ProtectorRanir, LLC · 2013
- This deviceK232238 Goyo Mouthpiece SDimedikorea · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K022809 | EZ Splint & EZ Splint PM | Power Products, Inc.-Splintek | 2003 | — |
| −5 | K072147 | Den Tek Comfort Fit Nightguard | Den Tek Oral Care, Inc. | 2007 | — |
| −4 | K082301 | Grind NO More | Placontrol, Inc. | 2008 | — |
| −3 | K091175 | Grind NO More Version 2 and 3 | Ranir, LLC | 2009 | — |
| −2 | K112879 | Rest Assured Ready to Wear Nite Protector | Ranir, LLC | 2012 | — |
| −1 | K133423 | Rest Assured Extra Comfort Nite Protector | Ranir, LLC | 2013 | — |
| 0 (this device) | K232238 | Goyo Mouthpiece S | Dimedikorea | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K133423 | Rest Assured Extra Comfort Nite ProtectorSummary page 5…Unclassified, Pre-Amendment Regulatory Class: Unclassified Product Code: OBR Classification Panel: Dental V. PREDICATE DEVICE K133423, Rest Assured® Extra Comfort Nite Protector / Ranir, LLC No reference devices were used in this submission. VI. DEVICE DESC… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- None of the 19 ancestors has a recall.
How does its category compare?
All OBR devicesOBR Mouthguard, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Goyo Mouthpiece S is indicated for use as a protection against bruxism or nighttime teeth grinding. The device is designed to reduce tooth damage and reduce the noise associated with bruxism or teeth grinding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232238 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232238: Goyo Mouthpiece S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232238
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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