T/CAMDI 084-2022 Additive manufacturing tantalum maxillary implant replacement prosthesis
T/CAMDI 084-2022 Additive manufacturing tantalum maxillary implant replacement prosthesis
Basic Information
Scope
Main technical content: This document specifies the requirements for the product design, materials, testing methods, quality control, manufacturing, post-processing, sterilization, packaging, and manufacturer's information of tantalum jawbone repair implants constructed primarily using additive manufacturing technology. This document applies to additive manufactured tantalum jawbone repair implants that are surgically implanted into the upper and lower jawbone of human jawbone defect sites to restore jawbone morphology and function and guide the growth of new bone. The additive manufactured tantalum jawbone repair implants referred to in this document do not include special designed medical devices such as bioprinted ones containing drug components, cells, tissues, and other bioactive substances. This document does not include dental implants.