510(k) · Cleared
ClearedMouth Guard (ATG0603R)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reazeal Corp · OBR Mouthguard, Over-The-Counter
Cleared on Nov 6, 2023 as substantially equivalent to K180933 (Medtech Products, Inc., 2018) after a 133-day review. Its family tree reaches back 5 generations to 2006. 1 later device descends from it.
- Decided
- Nov 6, 2023
- Review
- 133 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K053580 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK053580 Doctor's NightguardDental Concepts, LLC · 2006
- 4 generations backK063483 Den Tek NightguardDen Tek Oral Care, Inc. · 2007
- 3 generations backK083400 Custom Comfort NightguardDen Tek Oral Care, Inc. · 2008
- 2 generations backK091660 Custom Comfort Nightguard Version 2Den Tek Oral Care, Inc. · 2009
- 1 generation backK180933 DenTek Ultimate Dental GuardMedtech Products, Inc. · 2018
- This deviceK231865 Mouth Guard (ATG0603R)Reazeal Corp · 2023
- Descendant · cites it directly · 0 of its ownK252485 ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large…1987 Media Limited · 2026
Most influential descendants
Showing 1 of 1 · See all- K252485ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore…1987 Media Limited · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K053580 | Doctor's Nightguard | Dental Concepts, LLC | 2006 | — |
| −4 | K063483 | Den Tek Nightguard | Den Tek Oral Care, Inc. | 2007 | — |
| −3 | K083400 | Custom Comfort Nightguard | Den Tek Oral Care, Inc. | 2008 | — |
| −2 | K091660 | Custom Comfort Nightguard Version 2 | Den Tek Oral Care, Inc. | 2009 | — |
| −1 | K180933 | DenTek Ultimate Dental Guard | Medtech Products, Inc. | 2018 | — |
| 0 (this device) | K231865 | Mouth Guard (ATG0603R) | Reazeal Corp | 2023 | — |
| +1 | K252485 | ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size))… | 1987 Media Limited | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K180933 | DenTek Ultimate Dental GuardSummary page 5…ssification Name: Mouthguard, Over-the Counter Regulation Number: N/A Product Code: OBR Device Class: Unclassified Review Panel: Dental C. Predicate device: Predicate - K180933 DenTek Ultimate Dental Guard Medtech Products Inc. Reference device – K183315 CustMBite Dental Guard Dental Choice Holdings, LLC… | 2018 |
| † | K183315 | CustMBite Dental Guard | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252485 | ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore… | 2026 | 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?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K252485 (1987 Media Limited, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OBR devicesOBR Mouthguard, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Mouth Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231865 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231865: Mouth Guard (ATG0603R).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231865
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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