Brief Analysis of Clinical Evaluation Concerns of Personalized Abutments and Abutment Crown Bridge Products
10.12455/j.issn.1671-7104.230388
- VernacularTitle:浅析个性化基台及基台冠桥产品临床评价关注点
- Author:
Weilu CHENG
1
;
Yidan ZHANG
;
Li JI
;
Jiaying GUO
;
Qing ZHANG
;
Yinghui LIU
Author Information
1. 国家药品监督管理局医疗器械技术审评中心,北京市,100081
- Keywords:
personalized abutment;
abutment crown bridge;
clinical evaluation
- From:
Chinese Journal of Medical Instrumentation
2024;48(2):217-220
- CountryChina
- Language:Chinese
-
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.
