FDA 510(k)

柔性部分树脂

K号: K250302 · 2025-06-25

决定日期2025-06-25

产品代码EBI

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决定实质等同

器械摘要

Flexible Partial Resin 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 2025-06-25 under 510(k) number K250302. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Flexible Partial Resin?

Flexible Partial Resin is a medical device that received FDA 510(k) clearance on 2025-06-25. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K250302.

When did Flexible Partial Resin receive FDA 510(k) clearance?

Flexible Partial Resin received FDA 510(k) clearance on 2025-06-25, under 510(k) number K250302.

Who is the listed applicant for Flexible Partial Resin?

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 Flexible Partial Resin?

The FDA product code for Flexible Partial Resin is EBI.

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。