FDA 510(k)

BruxZir® Shaded 16 PLUS

K号: K254283 · 2026-01-30

决定日期2026-01-30

产品代码EIH

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决定实质等同

器械摘要

BruxZir® Shaded 16 PLUS 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 2026-01-30 under 510(k) number K254283. 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® Shaded 16 PLUS?

BruxZir® Shaded 16 PLUS is a medical device that received FDA 510(k) clearance on 2026-01-30. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K254283.

When did BruxZir® Shaded 16 PLUS receive FDA 510(k) clearance?

BruxZir® Shaded 16 PLUS received FDA 510(k) clearance on 2026-01-30, under 510(k) number K254283.

Who is the listed applicant for BruxZir® Shaded 16 PLUS?

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® Shaded 16 PLUS?

The FDA product code for BruxZir® Shaded 16 PLUS 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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