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 performance comparison tests for equivalence verification.
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http://dx.doi.org/10.12455/j.issn.1671-7104.230388 | DOI Listing |
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