FDA 510(k)

3Delta牙冠

K号: K211804 · 2021-12-06

决定日期2021-12-06

产品代码EBF

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决定实质等同

器械摘要

3Delta Crown is the device name listed in this FDA 510(k) record. The listed applicant is Deltamed GmbH. It received FDA 510(k) clearance on 2021-12-06 under 510(k) number K211804. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 3Delta Crown?

3Delta Crown is a medical device that received FDA 510(k) clearance on 2021-12-06. The listed applicant is Deltamed GmbH. The 510(k) number is K211804.

When did 3Delta Crown receive FDA 510(k) clearance?

3Delta Crown received FDA 510(k) clearance on 2021-12-06, under 510(k) number K211804.

Who is the listed applicant for 3Delta Crown?

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

What is the FDA product code for 3Delta Crown?

The FDA product code for 3Delta Crown is EBF.

列明Deltamed GmbH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。

K2437203Delta UNlimited K230341ACRIFIX K2125413Delta 牙托基座 - 3Delta 牙托粘合剂 - 3Delta 牙托固定器 K200039P pro牙冠和桥

官方来源

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