FDA 510(k)

DS Core Detect

K号: K253009 · 2026-01-07

决定日期2026-01-07

产品代码MYN

咨询委员会RA

决定实质等同

器械摘要

DS Core Detect 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 2026-01-07 under 510(k) number K253009. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DS Core Detect?

DS Core Detect is a medical device that received FDA 510(k) clearance on 2026-01-07. The listed applicant is Dentsply Sirona, Inc.. The 510(k) number is K253009.

When did DS Core Detect receive FDA 510(k) clearance?

DS Core Detect received FDA 510(k) clearance on 2026-01-07, under 510(k) number K253009.

Who is the listed applicant for DS Core Detect?

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 DS Core Detect?

The FDA product code for DS Core Detect is MYN.

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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