2021年合成树脂牙产品国家监督抽检情况分析  

Quality Analysis of Synthetic Resin Teeth in State Supervision and Sampling Inspection in 2021

作　　者：吴紫君 肖燕萍[1] 张庆松[1] 陈小君[1] WU Zi-jun;XIAO Yan-ping;ZHANG Qing-song;CHEN Xiao-jun(Guangdong Medical Devices Quality Surveillance and Test Institute,Guangdong Guangzhou 510080)

机构地区：[1]广东省医疗器械质量监督检验所,广东广州510080

出　　处：《中国医疗器械信息》2022年第1期7-10,共4页China Medical Device Information

摘　　要：2021年合成树脂牙产品国家监督抽检按照YY0300-2009《牙科学修复用人工牙》强制性行业标准、产品注册标准/产品技术要求进行检测。针对抽检情况,对合成树脂牙的现状和本次抽检中发现的不合格项目、注册生产配套的资料等问题进行分析,并提出相应的建议。In 2021,according to the mandatory industry standard which named YY0300-2009 Dentistry—Artificial teeth for dental prostheses,and product registration standard/product technical requirements standard,National Medical Products Administration performed spot tests on synthetic resin teeth.According to the spot tests,this artical is going to analyze the present situation of synthetic resin teeth,the unqualified items found in the sampling inspection,and the problems of the registered production supporting materials,and to put forward corresponding suggestions.

关 键 词：合成树脂牙 监督抽检 不合格 分析 建议 

分 类 号：TH781[机械工程—仪器科学与技术]