How To Perform Biocompatibility Evaluation On The Implant Products Processed Using Additive Manufacturing?

The implant is a solid in stud shape or other shapes implanted into alveolar bone to provide fixation and support for restorations such as denture, so as to restore the masticatory function of patients. For the implant products processed using additive manufacturing, the administrative counterpart should perform biocompatibility evaluation in combination with the surface modification treatment, residual powder dissolution and other characteristics of product materials, and with reference to GB/T 16886 series standards. The implant product is a medical device designed for implantation for longer than 30 days Where it is necessary to conduct the biological test, it is required to select the test items with reference to YY/T 0268 series standards, taking the subchronic systemic toxicity test into consideration.