510(k) · Cleared
ClearedRemvia NightGuard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remvia · MQC Mouthguard, Prescription
Cleared on Dec 5, 2025 as substantially equivalent to K193577 (Splintek, Inc., 2020) after a 269-day review. Its family tree reaches back 5 generations to 2003.
- Decided
- Dec 5, 2025
- Review
- 269 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K022809 (2003). 10 ancestors in all, the oldest K010876 (2001). No later device cites it as a predicate yet.
- Root · 5 generations backK022809 EZ Splint & EZ Splint PMPower Products, Inc.-Splintek · 2003
- 4 generations backK072147 Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc. · 2007
- 3 generations backK121272 Protech DentAkervall Technologies, Inc. · 2012
- 2 generations backK172223 SleepRight ProRx Custom Dental GuardSplintek, Inc. · 2017
- 1 generation backK193577 SleepRight ProRx Custom Dental GuardSplintek, Inc. · 2020
- This deviceK250743 Remvia NightGuardRemvia · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K022809 | EZ Splint & EZ Splint PM | Power Products, Inc.-Splintek | 2003 | — |
| −4 | K072147 | Den Tek Comfort Fit Nightguard | Den Tek Oral Care, Inc. | 2007 | — |
| −3 | K121272 | Protech Dent | Akervall Technologies, Inc. | 2012 | — |
| −2 | K172223 | SleepRight ProRx Custom Dental Guard | Splintek, Inc. | 2017 | — |
| −1 | K193577 | SleepRight ProRx Custom Dental Guard | Splintek, Inc. | 2020 | — |
| 0 (this device) | K250743 | Remvia NightGuard | Remvia | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 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 MQC? 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 MQC device
- #1 K203000 KeyPrint KeySplint Hardscore 15.3 · 5 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 |
|---|---|---|---|
| * | K193577 | SleepRight ProRx Custom Dental GuardSummary page 5…MQC Device Classification II III. Predicate Device Substantial equivalence is claimed to the following device: • SleepRight ProRX Custom Dental Guard, K193577, Splintek, Inc. The following reference device is cited within the submission: • SleepRight Select-ComfortDental Guard, K2127… | 2020 |
| † | K212767 | SleepRight Select-Comfort Dental Guard | 2021 |
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 22 years and passes through 5 companies; a new generation was cleared every 5.1 years on median.
- None of the 10 ancestors has a recall.
- 1 other device also cites its predicate K193577.
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MQC
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQC
185in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQC
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQC
7in 2025
MAUDE reports naming product code MQC, 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 | 4 | 79 | 0 | 9 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 4 | 194 | 0 | 2 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 3 | 234 | 0 | 5 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 2 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 71 |
| 2019 | 5 | 286 | 0 | 62 |
| 2020 | 4 | 204 | 0 | 46 |
| 2021 | 7 | 158 | 0 | 111 |
| 2022 | 5 | 120 | 0 | 137 |
| 2023 | 6 | 230 | 1 | 62 |
| 2024 | 8 | 249 | 0 | 8 |
| 2025 | 4 | 185 | 0 | 7 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Remvia NightGuard is indicated for:
• Protection against teeth grinding, bruxism, and jaw clenching
• Short-term pain relief from muscle spasm due to occlusal interference
• Prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.
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/K250743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250743: Remvia NightGuard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250743
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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