牙种植体产品结构设计技术审评关注点

Concern of Technical Review about dental Implant Product's Structural Design

牙种植体产品的结构设计是影响牙种植体产品临床使用安全有效性的关键因素。目前上市的牙种植体产品数以百计,基于临床医生和患者的需求、研发人员和生产企业思变创新,种植体产品结构设计不断推陈出新。本文就牙种植体产品的外形设计、尺寸设计、颈部设计、根端设计、种植体-基台连接设计、平台转移设计阐述了牙种植体结构设计的发展现状。结合该类产品上市注册的技术审评情况,对牙种植体产品结构设计相关的器械特征、性能研究、生产制造、典型性型号选择等技术审评关注点进行讨论,以期共同探讨如何科学有效控制牙种植体产品结构设计相关的临床使用风险,指导牙种植体系统产品的研发申报,提高技术审评效率,从而推动口腔种植产业蓬勃发展。

The structural design of dental implant product is a key factor that affects the safety and effectiveness of the dental implant product in clinical use. There are hundreds of dental implant products on the market at present, and new structural designs of the implant products have been introduced constantly based on the demands of the clinicians and the patients and the thinking of change and innovation of developers and manufacturers. This paper elaborates the development status of the structural design of the dental implants in respects of shape design, dimensional design, neck design, root apex design, implant-abutment connection design and platform switching design of the dental implant, and discusses the technical review focuses such as device characteristics, performance study, manufacture and typical model selection associated with the structural design of dental implant products in combination with the technical review conditions of the registration of such products, to jointly explore how to scientifically control clinical use risks associated with the structural design of dental implant products, improve the efficiency for technical review of dental implant products and promote and guide the research and development and production of dental implant products, so as to push forward the prosperous development of dental implant industry.