ProVectra 3D Prime with VistaSoft
K号: K181432 · 2018-08-02
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器械摘要
ProVectra 3D Prime with VistaSoft is the device name listed in this FDA 510(k) record. The listed applicant is Durr Dental SE. It received FDA 510(k) clearance on 2018-08-02 under 510(k) number K181432. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ProVectra 3D Prime with VistaSoft?
ProVectra 3D Prime with VistaSoft is a medical device that received FDA 510(k) clearance on 2018-08-02. The listed applicant is Durr Dental SE. The 510(k) number is K181432.
When did ProVectra 3D Prime with VistaSoft receive FDA 510(k) clearance?
ProVectra 3D Prime with VistaSoft received FDA 510(k) clearance on 2018-08-02, under 510(k) number K181432.
Who is the listed applicant for ProVectra 3D Prime with VistaSoft?
The FDA 510(k) record lists Durr Dental SE as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ProVectra 3D Prime with VistaSoft?
The FDA product code for ProVectra 3D Prime with VistaSoft is OAS.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Durr Dental SE为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：OAS）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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