FDA 510(k)

Tetric PowerFill

K号: K183380 · 2019-03-14

决定日期2019-03-14

产品代码EBF

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决定实质等同

器械摘要

Tetric PowerFill is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2019-03-14 under 510(k) number K183380. 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 Tetric PowerFill?

Tetric PowerFill is a medical device that received FDA 510(k) clearance on 2019-03-14. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K183380.

When did Tetric PowerFill receive FDA 510(k) clearance?

Tetric PowerFill received FDA 510(k) clearance on 2019-03-14, under 510(k) number K183380.

Who is the listed applicant for Tetric PowerFill?

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

What is the FDA product code for Tetric PowerFill?

The FDA product code for Tetric PowerFill is EBF.

列明Ivoclar Vivadent, AG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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