FDA 510(k)

Byte Aligner System

K号: K230199 · 2023-10-18

决定日期2023-10-18

产品代码NXC

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决定实质等同

器械摘要

Byte Aligner System 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 2023-10-18 under 510(k) number K230199. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Byte Aligner System?

Byte Aligner System is a medical device that received FDA 510(k) clearance on 2023-10-18. The listed applicant is Dentsply Sirona, Inc.. The 510(k) number is K230199.

When did Byte Aligner System receive FDA 510(k) clearance?

Byte Aligner System received FDA 510(k) clearance on 2023-10-18, under 510(k) number K230199.

Who is the listed applicant for Byte Aligner System?

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 Byte Aligner System?

The FDA product code for Byte Aligner System is NXC.

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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