BACKGROUND:Additive manufacturing technology provides strong technical support for personalized and precise medical treatment due to its rapid prototyping,digitalization,and personalization.Therefore,its medical devices have developed rapidly in orthopedics,oral,preoperative planning,craniomaxillofacial,and other clinical applications. OBJECTIVE:To briefly introduce the progress of additive manufacturing technology and its commercial application in the clinic in and outside China. METHODS:Wanfang Data,China National Knowledge Infrastructure(CNKI),PubMed,Elsevier,Springer Link databases,and the websites of National Medical Products Administration and FDA were searched using"additive manufacturing,medical device,clinical application,3D printing"as Chinese search terms and"additive manufacturing(AM),additive manufacturing technology,medical device,clinical application,3D printing"as English search terms.The search time ranged from January 2010 to March 2023,and a few classical long-term articles were included. RESULTS AND CONCLUSION:Additive manufacturing technology is classified by the form of raw materials(liquid-based,solid-based,and powder-based).At present,there are seven kinds of additive manufacturing processes,including fused deposition molding,stereo-curing molding,powder bed melting,directed energy deposition,binder jet 3D printing,inkjet printing,and layered solid manufacturing.The marketed additive manufacturing products include orthopedic products,dental products,preoperative planning guide plate/bone model products,and craniomaxillofacial products.The orthopedic products include matching long-segment bone defect restoration,interbody fusion cage,knee joint orthosis,vertebral prosthesis,thoracolumbar fusion matching prosthesis system,knee prosthesis,and hip prosthesis.Dental products include light-curing resin for additive manufacturing and BB Base 3D Printing Resin for Denture Base.The products of preoperative planning guide plates/bone models include bone models,medical orthopedic surgical guide plates,customized dental implant guide plates,and human organ models.The craniomaxillofacial products include polycaprolactone scaffolds,patient-specific skull implants,OsteoFab patient-specific face device,SpinFab VBR prosthesis,and TruMatch CMF titanium alloy 3D printing prosthesis system.

From the perspective of technical evaluation, this article introduces the focus of clinical evaluation of dental implants (systems) in comparison with the comparable devices and discusses the clinical evaluation of such products，combined with the clinical evaluation review of dental implants (systems) products in recent years, in order to provide reference for the registration of these products.
Dental Implants