| K-number | K250743 |
| Device name | Remvia NightGuard |
| Applicant | Remvia |
| Product code | MQC |
| Device class | Class U |
| Decision date | Dec 5, 2025 |
| Decision | Substantially Equivalent |
| Regulation | — |
The Remvia NightGuard is an intraoral mouthguard designed to protect against teeth grinding (bruxism), jaw clenching, and provide short-term pain relief from muscle spasm due to occlusal interference. It is worn passively during sleep and is retained in the posterior buccal vestibule and retromolar region using soft tissue support, without covering the teeth.
Both the Remvia NightGuard and predicate device are adjustable, pre-formed dental guards intended for passive intraoral wear during sleep. While the predicate achieves full occlusion of maxillary teeth, the subject device uses soft tissue retention mechanisms similar to the reference device. The devices differ in geometry and function but share similar safety profiles and intended use principles.
Not stated in this summary.
The Remvia NightGuard has identical indications for use as the predicate device (SleepRight ProRX Custom Dental Guard, K193577). Although differences in device geometry and function exist, the reference device (SleepRight Select-ComfortDental Guard, K212767) demonstrates clinical precedent for these differences. Material characterization and biocompatibility testing support that these differences do not raise new safety or effectiveness concerns, establishing substantial equivalence.
View the full FDA submission: accessdata.fda.gov