3D打印义齿注册申报重点及工艺控制难点分析

      Analysis for Key Points of Registration Applications and Difficulties of Process Control of 3D Printed Customized Dentures

      • 摘要: 随着3D打印技术在口腔修复领域的优势凸显,增材制造定制式义齿的注册申报数量日益增多,但工艺控制核心要素、注册申报重点及安全生产质量控制点尚缺乏统一梳理。该研究从调研行业现状入手,理清困惑及难点,对产品缺陷产生机理进行深入分析,梳理出工艺控制核心要素,进而尝试建立起从产品性能研究、关键工艺验证、生产质量控制到注册申报资料阐述的系统评价体系,为从业人员明确研究方向,建立质量管理体系,提高注册申报效率,确保产品质量提供帮助。

         

        Abstract: With the highlighted advantages of 3D printing technology in the field of dental prosthodontics, there is increasing in the numbers of registration applications for additive manufacturing customized dentures. However, there is still a lack of unified analysis in the core elements of process control, the key points of registration and the safety production quality control. Based on the current research status of the industry, the study is intended to clarify confusion and difficulties, deeply analyse the mechanism of the product defects, sort the core elements of process control, then try to establish a systematic evaluation system from product performance research, key process verification, production quality control and the description of registration files, so that it can provide help for practitioners to clarify research direction, establishing quality management system, improving the efficiency of registration and ensuring product quality.

         

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