510(k) · Cleared
ClearedDreamgard Rem-Soft, Dreamgard Rem-Lite, Dreamgard Rem-Ultra, Dreamgard Rem-Max
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dreamgard, Inc. · MQC Mouthguard, Prescription
Cleared on Jan 19, 2012 as substantially equivalent to K040315 (Mci-Myohealth Systems, 2004) after a 111-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Jan 19, 2012
- Review
- 111 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K981546 (1998). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K1024261 | Dental Concepts Bite Plate Number could not be read Summary page 2…Device Applicant - 510(K) Dental Concepts Bite Plate IDental Concepts 1024261 K Myohealth Clenching… | |
| * | K040315 | Myohealth Clenching InhibitorSummary page 3…al characteristics, design, and principles of operation. All devices are composed of thermo- formable resins. The Dreamgard nightguards and the MCI Clenching Inhibitor (K0403 15) are both custom fabricated by the dentist using standard industry impression material and tray. The impression is converted into… | 2004 |
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 14 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K040315.
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Dreamgard nightguards are indicated for protection against bruxism (nighttime teeth grinding) and jaw clenching during sleep, short-term pamn relief from muscle spasm due to occlusal interference, and prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the posterior mandibular and maxillary teeth by the temporalis muscle
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112868 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112868: Dreamgard Rem-Soft, Dreamgard Rem-Lite, Dreamgard Rem-Ultra, Dreamgard Rem-Max.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112868
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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