Remi Impression Material

The Remi Impression Material is an addition-cure silicone impression material in putty consistency, composed of vinyl polysiloxane and fillers with neutral smell. It is placed on a preformed impression tray to capture the structure of a patient's teeth and gums for fabricating custom over-the-counter nightguards and mouthguards.

The device is Type 0 putty consistency with vinyl polysiloxane material, 1:1 mixing ratio, non-sterile removable format, setting time of 60–120 seconds, hardness of 58±2 Shore A, dimensional accuracy >99%, and linear dimensional stability of 0.69%. It is identical in material composition and design to the predicate device with no formulation changes.

ISO 4823 for impression material consistency and performance; ISO 10993 for biocompatibility.

The Remi Impression Material is substantially equivalent to the predicate (Accusil Putty, K213244) because it has identical technological features, material composition, design, and principle of operation. The change in indication from prescription to over-the-counter use is supported by human factors testing demonstrating lay users can safely self-administer the kit, and a clinical study showing impressions taken at home produce nightguards equivalent in fit and quality to professionally-taken impressions, with no adverse events reported.