FDA 510(k)

Primescan 2

K号: K250771 · 2025-08-29

决定日期2025-08-29

产品代码NTK

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决定实质等同

器械摘要

Primescan 2 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 2025-08-29 under 510(k) number K250771. The device is classified under product code NTK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Primescan 2?

Primescan 2 is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is Dentsply Sirona, Inc.. The 510(k) number is K250771.

When did Primescan 2 receive FDA 510(k) clearance?

Primescan 2 received FDA 510(k) clearance on 2025-08-29, under 510(k) number K250771.

Who is the listed applicant for Primescan 2?

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 Primescan 2?

The FDA product code for Primescan 2 is NTK.

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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