Remi Custom Night Guard

The Remi Custom Night Guard is a mouth guard worn on maxillary or mandibular teeth to protect teeth and dental restorations from damage caused by grinding and clenching (bruxism) by creating physical separation between upper and lower tooth surfaces. It is indicated for prescription use and is non-sterile and patient-removable.

The device uses the same mechanism of action as the predicate LIJIA Night Guard—a thermoplastic material barrier intended to be worn on teeth to protect against grinding and clenching and mitigate temporomandibular disorder pain. Both devices use thermoplastic materials with identical product codes, classification panels, device classes, and anatomical sites.

ISO 10993 biocompatibility testing including cytotoxicity testing. Durability testing and internal manufacturing validation for dimensional accuracy of the manufacturing process were completed.

The device is substantially equivalent because it shares identical indications for use, anatomical sites, product code (MQC), device classification (Unclassified), sterility status (non-sterile), and patient-removable design with the predicate LIJIA Night Guard. The materials, manufacturing processes, and technological characteristics are the same or similar, and biocompatibility testing demonstrates safety comparable to the predicate, eliminating the need for clinical studies.