EsFlow PLUS

EsFlow PLUS is a light-cured, radiopaque flowable composite resin used for direct dental restorations. It is applied smoothly to teeth, offering good gloss and aesthetics with high mechanical strength to withstand occlusal forces. It has two viscosities for various clinical applications including direct restorations, base and liner, block out undercut, repair of indirect aesthetic restorations, and core build-up.

EsFlow PLUS has a particle size range of 0.01 to 0.5 μm with a volume ratio of 42 to 47% depending on the model. It has a longer light curing time than the predicate device but both have similar intended operators and storage temperature limits. Both devices meet ISO 4049 requirements with comparable performance characteristics.

ISO 4049 (composite resin properties), ISO 9917-1 (compressive strength testing). Depth of cure, flexural strength, and compressive strength tests were performed on both the subject and predicate devices per these standards.

EsFlow PLUS is substantially equivalent because it shares the same principle of operation, biocompatibility, application area, and target population as the predicate device (G-zenial Universal Injectable). Performance testing shows the subject device meets or exceeds ISO 4049 requirements with depth of cure, flexural strength, and compressive strength values equal to or better than the predicate, raising no new safety or effectiveness concerns despite differences in curing time.