priti 多功能 ZrO2 高透明度
K号: K161025 · 2017-02-03
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决定日期2017-02-03
产品代码EIH
咨询委员会DE
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决定实质等同
器械摘要
priti multidisc ZrO2 High Translucent is the device name listed in this FDA 510(k) record. The listed applicant is Pritidenta GmbH. It received FDA 510(k) clearance on 2017-02-03 under 510(k) number K161025. 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 priti multidisc ZrO2 High Translucent?
priti multidisc ZrO2 High Translucent is a medical device that received FDA 510(k) clearance on 2017-02-03. The listed applicant is Pritidenta GmbH. The 510(k) number is K161025.
When did priti multidisc ZrO2 High Translucent receive FDA 510(k) clearance?
priti multidisc ZrO2 High Translucent received FDA 510(k) clearance on 2017-02-03, under 510(k) number K161025.
Who is the listed applicant for priti multidisc ZrO2 High Translucent?
The FDA 510(k) record lists Pritidenta GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for priti multidisc ZrO2 High Translucent?
The FDA product code for priti multidisc ZrO2 High Translucent is EIH.
相关临床试验
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相关器械（代码：EIH）
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。
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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