FDA 510(k)

BruxZir® NOW

K号: K252446 · 2025-09-03

决定日期2025-09-03

产品代码EIH

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决定实质等同

器械摘要

BruxZir® NOW 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 2025-09-03 under 510(k) number K252446. 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® NOW?

BruxZir® NOW is a medical device that received FDA 510(k) clearance on 2025-09-03. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K252446.

When did BruxZir® NOW receive FDA 510(k) clearance?

BruxZir® NOW received FDA 510(k) clearance on 2025-09-03, under 510(k) number K252446.

Who is the listed applicant for BruxZir® NOW?

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® NOW?

The FDA product code for BruxZir® NOW 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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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。