510(k) · Cleared
ClearedGrind Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Archtek, Inc. · OBR Mouthguard, Over-The-Counter
Cleared on Feb 8, 2008 as substantially equivalent to K053580 (Dental Concepts, LLC, 2006) after a 63-day review. Its family tree reaches back 1 generation to 2006. 2 later devices descend from it.
- Decided
- Feb 8, 2008
- Review
- 63 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053580 (2006). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK053580 Doctor's NightguardDental Concepts, LLC · 2006
- This deviceK073446 Grind GuardArchtek, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK111310 Brux MouthguardsDental Arte, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK090472 Grind GuardArchtek, Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053580 | Doctor's Nightguard | Dental Concepts, LLC | 2006 | — |
| 0 (this device) | K073446 | Grind Guard | Archtek, Inc. | 2008 | — |
| +1 | K111310 | Brux Mouthguards | Dental Arte, Inc. | 2011 | — |
| +1 | K090472 | Grind Guard | Archtek, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K053580 | Doctor's NightguardSummary page 1…ssociated with bruxism or grinding. Predicate Device Information: This device is substantially equivalent to the Doctor's Night Guard, marketed by Dental Concepts under K053580. Comparison to Predicate Device(s): The Grind Guard is substantially equivalent with regard to indications for use, general tech… | 2006 |
What descends from it? (2)
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?
How does its category compare?
All OBR devicesOBR Mouthguard, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Protection against bruxism or nighttime teeth grinding; to reduce
damage to teeth, and to prevent the noise associated with bruxism or grinding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073446: Grind Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073446
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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