If The Abutment Product Has Undergone Colored Anodizing Treatment, How To Submit The Biological Evaluation Data?

For the abutment products which have undergone colored anodizing, it is necessary to perform biological evaluation according to the “Notice on Issuing the Guidelines for Biological Evaluation and Review of Medical Devices” (CFDA [2007] No. 345), GB/T 16886 and YY/T 0268 series standards and to perform analysis on the surface elements of product; if any impurity element other than matrix element is contained, it is necessary to analyze the source of surface impurity element and the reason for the introduction thereof, conduct full demonstration on biological risks of the product caused, and clarify the corresponding quality control process and risk prevention and control measures for colored anodizing.