FDA 510(k)

DD 对比剂

K号: K193588 · 2020-04-16

决定日期2020-04-16

产品代码EIH

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决定实质等同

器械摘要

DD Contrast is the device name listed in this FDA 510(k) record. The listed applicant is Dental Direkt GmbH. It received FDA 510(k) clearance on 2020-04-16 under 510(k) number K193588. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DD Contrast?

DD Contrast is a medical device that received FDA 510(k) clearance on 2020-04-16. The listed applicant is Dental Direkt GmbH. The 510(k) number is K193588.

When did DD Contrast receive FDA 510(k) clearance?

DD Contrast received FDA 510(k) clearance on 2020-04-16, under 510(k) number K193588.

Who is the listed applicant for DD Contrast?

The FDA 510(k) record lists Dental Direkt GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DD Contrast?

The FDA product code for DD Contrast is EIH.

列明Dental Direkt GmbH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。

K241579DD 混合层（多彩氧化锆）K230410DD 医疗聚合物（PMMA）K230218DD Solid Connect® CAD/CAM 牙槽（进一步 DD Ti-Base 2CUT 系列）K191111DD Solid Connect® CAD/CAM 牙槽 K183569DD cube ONE ML K170885DD cubeX2 HS

查看所有 8 个设备 →

官方来源

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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。