FDA 510(k)

Primevision 3D

K号: K253959 · 2026-02-05

决定日期2026-02-05

产品代码OAS

咨询委员会RA

决定实质等同

器械摘要

Primevision 3D is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2026-02-05 under 510(k) number K253959. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Primevision 3D?

Primevision 3D is a medical device that received FDA 510(k) clearance on 2026-02-05. The listed applicant is Dentsply Sirona. The 510(k) number is K253959.

When did Primevision 3D receive FDA 510(k) clearance?

Primevision 3D received FDA 510(k) clearance on 2026-02-05, under 510(k) number K253959.

Who is the listed applicant for Primevision 3D?

FDA 510(k)记录中列出Dentsply Sirona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 Primevision 3D?

The FDA product code for Primevision 3D is OAS.

列明Dentsply Sirona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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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。