FDA 510(k)

BruxZir™ 切端着色液体

K号: K230262 · 2023-05-16

决定日期2023-05-16

产品代码EIH

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决定实质等同

器械摘要

BruxZir™ Incisal Coloring Liquid is the device name listed in this FDA 510(k) record. The listed applicant is Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2023-05-16 under 510(k) number K230262. 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 BruxZir™ Incisal Coloring Liquid?

BruxZir™ Incisal Coloring Liquid is a medical device that received FDA 510(k) clearance on 2023-05-16. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K230262.

When did BruxZir™ Incisal Coloring Liquid receive FDA 510(k) clearance?

BruxZir™ Incisal Coloring Liquid received FDA 510(k) clearance on 2023-05-16, under 510(k) number K230262.

Who is the listed applicant for BruxZir™ Incisal Coloring Liquid?

FDA 510(k)记录将Prismatik Dentalcraft, Inc.列为申请人。这本身并不足以确立该设备的制造商。

What is the FDA product code for BruxZir™ Incisal Coloring Liquid?

The FDA product code for BruxZir™ Incisal Coloring Liquid is EIH.

列明Prismatik Dentalcraft, Inc.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。

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