[Brief Analysis of Clinical Evaluation Concerns of Personalized Abutments and Abutment Crown Bridge Products].

Weilu Cheng, Yidan Zhang, Li Ji, Jiaying Guo, Qing Zhang, Yinghui Liu
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引用次数: 0

Abstract

Objective: The applications of personalized abutments and abutment crown bridge products have increased year by year, but there is no clear requirement for clinical evaluation of the same variety of such products. This study mainly introduces the clinical evaluation concerns of personalized abutments and abutment crown bridge products, in order to provide reference for the declaration and registration of such products.

Methods: The clinical evaluation of personalized abutments and crown bridge products are summarized, and the research content of clinical evaluation is clarified.

Results: The clinical evaluation requirements that need to be considered by enterprises are introduced.

Conclusion: Personalized abutment and abutment crown bridge products can refer to this study when they are launched in China, mainly using in vitro performance comparison tests for equivalence verification.

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[简析个性化基台和基冠桥产品的临床评估问题】。]
目的:个性化基台和基台冠桥产品的应用逐年增多,但对同类产品的临床评价却没有明确的要求。本研究主要介绍个性化基台和基冠桥产品的临床评价关注点,以期为此类产品的申报和注册提供参考:方法:总结了个性化基台和冠桥产品的临床评价,明确了临床评价的研究内容:结果:介绍了企业需要考虑的临床评价要求:结论:个性化基台和基冠桥产品在国内上市时可参考本研究,主要采用体外性能对比试验进行等效性验证。
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来源期刊
中国医疗器械杂志
中国医疗器械杂志 Medicine-Medicine (all)
CiteScore
0.40
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0.00%
发文量
8086
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