定制式义齿的产品质量分析  

Quality analysis of custom denture

作　　者：王文荣[1] 肖燕萍[1] 陈小君[1] 白伟[2] 韩建民[2] 

机构地区：[1]国家食品药品监督管理局广州医疗器械质量监督检验中心 [2]北京大学口腔医学院口腔材料研究室

出　　处：《口腔材料器械杂志》2017年第3期164-168,共5页Chinese Journal of Dental Materials and Devices

摘　　要：国家在2014年首次在全国范围内开展定制式义齿的监督抽验工作,抽验结果显示,最经常使用的非贵金属烤瓷类固定义齿和金属支架可摘局部活动义齿产品的合格率分别仅为54.2%和47.1%。主要的不合格项目包括设计文件、耐急冷热性能、孔隙度、表面质量、铸造连接体和卡环厚度等。本文建议应加强医生与生产企业的沟通,规范行业管理,提高生产工艺,确保义齿的产品质量。SFDA for the first time in nationwide carried out the supervision and sampling of custom denture in 2014, and the inspection results displayed, the product quali？cation rate for the most frequently used non-precious metal porcelain？xed partial dentures and removable partial denture with metal stent is only 54.2% and 47.1%, respectively. The major substandard items includeddesign document, resistance to thermal shock, porosity, surface quality, thickness of connector and clasp. It is recommended to strengthen the communication between clinicians and production enterprises, to standardize the management of industry, to improve the production process and thus to ensure the quality of the custom denture.

关 键 词：义齿 技术要求 质量分析 

分 类 号：TH787[机械工程—仪器科学与技术]