FDA 510(k)

Fixtemp C&B

K号: K171729 · 2017-12-13

决定日期2017-12-13

产品代码EBG

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决定实质等同

器械摘要

Fixtemp C&B is the device name listed in this FDA 510(k) record. The listed applicant is Dreve Dentamid GmbH. It received FDA 510(k) clearance on 2017-12-13 under 510(k) number K171729. 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 Fixtemp C&B?

Fixtemp C&B is a medical device that received FDA 510(k) clearance on 2017-12-13. The listed applicant is Dreve Dentamid GmbH. The 510(k) number is K171729.

When did Fixtemp C&B receive FDA 510(k) clearance?

Fixtemp C&B received FDA 510(k) clearance on 2017-12-13, under 510(k) number K171729.

Who is the listed applicant for Fixtemp C&B?

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

What is the FDA product code for Fixtemp C&B?

The FDA product code for Fixtemp C&B is EBG.

列明Dreve Dentamid 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。

K250739Primeprint直接矫正器 K200580FotoDent 假牙 K190571StoneBite 和 StoneBite 扫描 K171562Dynax 清晰型，Dynax 腊状，Dynax 重型，Dynax 轻型，Dynax 单一型 K162408表面纳米清漆，Plaquit，Lightpaint

官方来源

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