FDA 510(k)

Bluephase Style 20i

K号: K163613 · 2017-04-04

决定日期2017-04-04

产品代码EBZ

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决定实质等同

器械摘要

Bluephase Style 20i 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 2017-04-04 under 510(k) number K163613. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Bluephase Style 20i?

Bluephase Style 20i is a medical device that received FDA 510(k) clearance on 2017-04-04. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K163613.

When did Bluephase Style 20i receive FDA 510(k) clearance?

Bluephase Style 20i received FDA 510(k) clearance on 2017-04-04, under 510(k) number K163613.

Who is the listed applicant for Bluephase Style 20i?

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 Bluephase Style 20i?

The FDA product code for Bluephase Style 20i is EBZ.

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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