Abstract: Objective: To evaluate the biological safety of newly synthesized composite material PEEK. Methods: MTT assay, acute systemic toxicity test, hemolysis test, and mucosa irritation test were employed to detect the biological safety of PEEK composite materials in vitro and in vivo. Results: The results of cytotoxicity test showed that cells grew well in the extract fluids of PEEK composite and there was no significant difference between experimental group and control group. The results of acute systemic toxicity test showed that all rats in the experimental group were alive, with normal diet and good mental state during the observation period. After the rats were injected with the extract fluids, there were no pathological changes in their hearts, livers, kidneys and spleens organs when observed by naked eye and microscopes. The results of mucous membrane irritation test showed that PEEK composite had no irritation to oral mucosa membrane. The result of hemolysis test showed that the PEEK composite did not cause hemolytic reaction. Conclusion: PEEK composite has biological safety.

Key words: Biocompatibility, Polyetheretherketone, Dental material