FDA 510(k)

迪玛打印牙齿与温度计

K号: K233868 · 2024-05-23

决定日期2024-05-23

产品代码EBG

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决定实质等同

器械摘要

dima Print Teeth & Temp is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, LLC. It received FDA 510(k) clearance on 2024-05-23 under 510(k) number K233868. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the dima Print Teeth & Temp?

dima Print Teeth & Temp is a medical device that received FDA 510(k) clearance on 2024-05-23. The listed applicant is Kulzer, LLC. The 510(k) number is K233868.

When did dima Print Teeth & Temp receive FDA 510(k) clearance?

dima Print Teeth & Temp received FDA 510(k) clearance on 2024-05-23, under 510(k) number K233868.

Who is the listed applicant for dima Print Teeth & Temp?

The FDA 510(k) record lists Kulzer, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for dima Print Teeth & Temp?

The FDA product code for dima Print Teeth & Temp is EBG.

列明Kulzer, LLC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。

K260783维纳斯钻石；维纳斯钻石流；维纳斯珍珠；维纳斯大流量一 K254063iCEM通用增强型 K243910Retraxil K240660Signum 复合流；Signum 通用粘合剂；Signum 金属粘合剂；Signum 复合；Signum 矩阵；Signum 液体；Signum cre-active K230644Signum 不透明 F K220605维纳斯大流量ONE

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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。