510(k) · Cleared
ClearedRemi Custom Night Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remi · OBR Mouthguard, Over-The-Counter
Cleared on Oct 17, 2025 as substantially equivalent to K221369 (Fbcc, Inc., 2022) and 1 other predicate after a 129-day review. Its family tree reaches back 9 generations to 1989. 1 later device descends from it.
- Decided
- Oct 17, 2025
- Review
- 129 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K882303 (1989). 21 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 5 generations between
- 3 generations backK133037 GrindguardGrind Guard Technologies, LLC · 2014
- 2 generations backK181099 Bright GuardKoncept Innovators, LLC · 2019
- 1 generation backK221369 FBCC Night GuardFbcc, Inc. · 2022
- This deviceK251778 Remi Custom Night GuardRemi · 2025
- Descendant · cites it directly · 0 of its ownK253641 Owl Night GuardOwl Dental Lab, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 8 generations backK014079 DR. Hays Bite GuardInventive Resources, Inc. · 2002
- 7 generations backK024261 Dental ProtectorDental Concepts, LLC · 2003
- 6 generations backK073220 The Doctor's Nightguard Advanced ComfortPrestige Brands, Inc. · 2007
- 5 generations backK082723 GrindguardGrind Guard Technologies, LLC · 2009
- 4 generations backK123161 Smartguard Night Guard, Smartguard Original, Smartguard Night Guard…Smartguard, Inc. · 2013
- 3 generations backK133037 GrindguardGrind Guard Technologies, LLC · 2014
- 2 generations backK181099 Bright GuardKoncept Innovators, LLC · 2019
- 1 generation backK221369 FBCC Night GuardFbcc, Inc. · 2022
- This deviceK251778 Remi Custom Night GuardRemi · 2025
Most influential descendants
Showing 1 of 1 · See all- K253641Owl Night GuardOwl Dental Lab, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −8 | K014079 | DR. Hays Bite Guard | Inventive Resources, Inc. | 2002 | — |
| −7 | K024261 | Dental Protector | Dental Concepts, LLC | 2003 | — |
| −6 | K073220 | The Doctor's Nightguard Advanced Comfort | Prestige Brands, Inc. | 2007 | — |
| −5 | K082723 | Grindguard | Grind Guard Technologies, LLC | 2009 | — |
| −4 | K123161 | Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original… | Smartguard, Inc. | 2013 | — |
| −3 | K133037 | Grindguard | Grind Guard Technologies, LLC | 2014 | — |
| −2 | K181099 | Bright Guard | Koncept Innovators, LLC | 2019 | — |
| −1 | K221369 | FBCC Night Guard | Fbcc, Inc. | 2022 | — |
| 0 (this device) | K251778 | Remi Custom Night Guard | Remi | 2025 | — |
| +1 | 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 |
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 K253641 Owl Night Guardscore 13.6 · 10 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 |
|---|---|---|---|
| * | K221369 | FBCC Night GuardSummary page 5…Mouth Guard Product Code: OBR, OCO Device Classification: Unclassified Primary Predicate Device: FBCC Night Guard (K221369) Secondary Predicate Device: NTI Clench Guard (K211158) Reference Device: Thermoforming Sheet Materials (… | 2022 |
| * | K211158 | NTI ClenchGuardSummary page 5…OCO Device Classification: Unclassified Primary Predicate Device: FBCC Night Guard (K221369) Secondary Predicate Device: NTI Clench Guard (K211158) Reference Device: Thermoforming Sheet Materials (K200125) Device Description: The Remi Night Guard is a mout… | 2021 |
| † | K200125 | Thermoforming Sheet Materials | 2020 |
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 |
|---|---|---|---|
| K253641 | Owl Night Guard | 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 36 years and passes through 9 companies; a new generation was cleared every 3.5 years on median.
- None of the 21 ancestors has a recall.
- Of its descendants, K253641 (Owl Dental Lab, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K221369.
How does its category compare?
All OBR devicesOBR Mouthguard, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Remi Custom 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/K251778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251778: Remi Custom 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/K251778
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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