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["钽涂层牙种植体系统","钽涂层牙种植体系统由牙种植体及覆盖螺钉组成，其中牙种植体表面经喷砂酸蚀处理后镀钽，可耐腐蚀，覆盖螺钉表面有着色阳极氧化处理和非阳极氧化两种。牙种植体由TA4G纯钛材料制造，材料应符合GB/T 13810-2017的规定；牙种植体表面为纯钽涂层，纯钽材料应符合YY/T 0966-2014的规定；覆盖螺钉由TC4钛合金材料制造，材料应符合GB/T 13810-2017的规定。产品以无菌方式提供，灭菌方式为Co60射线辐照灭菌。","通过外科手术方式将产品植入人体缺牙部位的上下颌牙槽骨内，用于为义齿等修复体提供固定或支撑，以恢复患者的咀嚼功能。","17","08 口腔植入及组织重建材料","01牙种植体","Ⅲ","临床试验","可考虑采用单组设计"]