510(k) · Cleared
ClearedOwl Night Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Owl Dental Lab, Inc. · OBR Mouthguard, Over-The-Counter
Cleared on Feb 26, 2026 as substantially equivalent to K251778 (Remi, 2025) and 1 other predicate after a 99-day review. Its family tree reaches back 10 generations to 1989.
- Decided
- Feb 26, 2026
- Review
- 99 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K882303 (1989). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 6 generations between
- 3 generations backK181099 Bright GuardKoncept Innovators, LLC · 2019
- 2 generations backK221369 FBCC Night GuardFbcc, Inc. · 2022
- 1 generation backK251778 Remi Custom Night GuardRemi · 2025
- This deviceK253641 Owl Night GuardOwl Dental Lab, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 9 generations backK014079 DR. Hays Bite GuardInventive Resources, Inc. · 2002
- 8 generations backK024261 Dental ProtectorDental Concepts, LLC · 2003
- 7 generations backK073220 The Doctor's Nightguard Advanced ComfortPrestige Brands, Inc. · 2007
- 6 generations backK082723 GrindguardGrind Guard Technologies, LLC · 2009
- 5 generations backK123161 Smartguard Night Guard, Smartguard Original, Smartguard Night Guard…Smartguard, Inc. · 2013
- 4 generations backK133037 GrindguardGrind Guard Technologies, LLC · 2014
- 3 generations backK181099 Bright GuardKoncept Innovators, LLC · 2019
- 2 generations backK221369 FBCC Night GuardFbcc, Inc. · 2022
- 1 generation backK251778 Remi Custom Night GuardRemi · 2025
- This deviceK253641 Owl Night GuardOwl Dental Lab, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −9 | K014079 | DR. Hays Bite Guard | Inventive Resources, Inc. | 2002 | — |
| −8 | K024261 | Dental Protector | Dental Concepts, LLC | 2003 | — |
| −7 | K073220 | The Doctor's Nightguard Advanced Comfort | Prestige Brands, Inc. | 2007 | — |
| −6 | K082723 | Grindguard | Grind Guard Technologies, LLC | 2009 | — |
| −5 | K123161 | Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original… | Smartguard, Inc. | 2013 | — |
| −4 | K133037 | Grindguard | Grind Guard Technologies, LLC | 2014 | — |
| −3 | K181099 | Bright Guard | Koncept Innovators, LLC | 2019 | — |
| −2 | K221369 | FBCC Night Guard | Fbcc, Inc. | 2022 | — |
| −1 | K251778 | Remi Custom Night Guard | Remi | 2025 | — |
| 0 (this device) | 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 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K251778 | Remi Custom Night GuardSummary page 5…uth Guard Product Code: OBR, MQC, OCO Device Classification: Unclassified Primary Predicate Device: Remi Custom Night Guard (K251778) Secondary Predicate Device: NTI Clench Guard (K211158) Reference Device: Thermoforming Sheet Materials (K… | 2025 |
| * | K211158 | NTI ClenchGuardSummary page 5…Device Classification: Unclassified Primary Predicate Device: Remi Custom Night Guard (K251778) Secondary Predicate Device: NTI Clench Guard (K211158) Reference Device: Thermoforming Sheet Materials (K200125) Device Description: The Owl Night Guard is a mouth… | 2021 |
| † | K200125 | Thermoforming Sheet Materials | 2020 |
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 37 years and passes through 10 companies; a new generation was cleared every 3.5 years on median.
- None of the 22 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. 2026, 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 Owl Night Guard is Indicated for protection of teeth and restorations against grinding and clenching, and as an aid in the reduction of medically diagnosed migraine pain associated with jaw clenching and bruxing.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253641 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253641: Owl Night Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253641
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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