EsCem RMGI

EsCem RMGI is a radiopaque resin-modified glass ionomer luting cement used for final cementation of indirect dental restorations including metal, resin, ceramic, and zirconia inlays, onlays, crowns, bridges, and posts. It is provided as a dual-syringe automix system and includes a tack-cure option for excess cement removal.

EsCem RMGI and its predicate (RelyX Luting Plus Automix) share the same principle of operation, biocompatibility profile, self-curing setting time, application area, and intended operator. The subject device demonstrates slightly higher flexural strength, film thickness, and radiopacity than the predicate, but both meet ISO 9917-2 requirements with comparable mechanical performance values.

ISO 9917-2 (dental resin-modified glass ionomer cement requirements), ISO 10993-1 (biocompatibility evaluation framework), ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (skin sensitization), and ISO 10993-23 (irritation testing).

The device is substantially equivalent because its indications for use are entirely encompassed within the predicate's indications, both products function through identical operational principles and biocompatibility, and both comply with the same ISO 9917-2 standard with comparable mechanical performance. Although EsCem RMGI exhibits slightly enhanced flexural strength and film thickness, these improvements do not alter its fundamental intended use or safety profile relative to the predicate.