浅析牙科种植体(系统)类产品临床评价关注点
Analysis on Focus of Clinical Evaluation of Dental Implants (Systems)
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摘要: 从技术评价角度,结合近年来牙科种植体(系统)产品的临床评价审评情况,介绍牙科种植体(系统)同品种比对临床评价的关注点,探讨该类产品的临床评价审评的思路,以期对该类产品的申报注册提供参考。Abstract: From the perspective of technical evaluation, this article introduces the focus of clinical evaluation of dental implants (systems) in comparison with the comparable devices and discusses the clinical evaluation of such products,combined with the clinical evaluation review of dental implants (systems) products in recent years, in order to provide reference for the registration of these products.