FDA 510(k)

塑料外科工具包

K号: K251300 · 2025-07-22

决定日期2025-07-22

产品代码KCT

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Plastic Surgical Kits is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2025-07-22 under 510(k) number K251300. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Plastic Surgical Kits?

Plastic Surgical Kits is a medical device that received FDA 510(k) clearance on 2025-07-22. The listed applicant is Dentsply Sirona, Inc.. The 510(k) number is K251300.

When did Plastic Surgical Kits receive FDA 510(k) clearance?

Plastic Surgical Kits received FDA 510(k) clearance on 2025-07-22, under 510(k) number K251300.

Who is the listed applicant for Plastic Surgical Kits?

FDA 510(k)记录中列出Dentsply Sirona, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Plastic Surgical Kits?

The FDA product code for Plastic Surgical Kits is KCT.

列明Dentsply Sirona, 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。