What should be considered in the synthesis of composite resins for dental fillings in comparison with similar products (marketed domestically and internationally) or predecessor products?

Date:2024-10-25   Click:

The applicant should summarize the current status and development trend of research and clinical use of similar products at home and abroad. Comparison between the declared products and reference products (similar products or predecessor products) in terms of working principle, structural composition, manufacturing materials, performance indicators, scope of application, mode of action, application technology, etc. The comparison of the structural composition should clearly show the differences between the product composition and content. Comparison of performance indicators should focus on the description of dental filling with composite resin category typing, working time, curing time, sensitivity to ambient light, curing mode and conditions, curing depth, flexural strength, modulus of elasticity, surface polishing performance, wear resistance, polymerization and shrinkage characteristics, color and color stability, X-ray radioactivity, water-absorbent value, solubility value, residual monomers dissolved in the amount of heavy metal content, substance release (such as fluoride ion release) and so on. Release (such as fluoride ion release) and other major performance line comparison.



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