Remi Custom Night Guard

The Remi Custom Night Guard is an over-the-counter mouth guard worn on the upper or lower teeth at night to protect teeth and dental restorations from damage caused by grinding and clenching (bruxism). It also serves as an aid in reducing medically diagnosed migraine pain associated with jaw clenching and bruxing.

The device uses the same mechanism of action as predicate devices—physical separation of upper and lower tooth surfaces to prevent grinding damage. It is non-sterile, patient-removable, and manufactured using impressions and/or scans. It is intended for use in adults 18 years and older.

Durability testing, dimensional accuracy manufacturing validation, and biocompatibility assessment testing per FDA Guidance, ISO 10993-1 (Biological evaluation of medical devices—Part 1), and ISO 7405 (Dentistry—Evaluation of biocompatibility of medical devices used in dentistry).

The Remi Night Guard is substantially equivalent to the FBCC Night Guard (K221369) and NTI Clench Guard (K211158) based on identical indications for use, same user population (adults 18+), matching anatomical site of use, identical mechanism of action, and equivalent mechanical and technological features. No new clinical studies were required to establish substantial equivalence.