Owl Night Guard

The Owl Night Guard is a custom-manufactured mouth guard worn on the teeth during sleep to protect teeth and restorations from damage caused by grinding and clenching (bruxism). It is also indicated 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 between upper and lower tooth surfaces to prevent damage. It is a removable, non-sterile device manufactured using impressions and/or scans, worn on maxillary or mandibular teeth, and available for both OTC and prescription use.

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

The Owl Night Guard is substantially equivalent to the primary predicate (Remi Night Guard, K251778) and secondary predicate (NTI Clench Guard, K211158) based on identical indications for use, same user population (adults 18+), matching mechanical and technological features, and comparable anatomical sites of use.