FDA 510(k)

VITA ENAMIC 器械解决方案（IS）

K号: K153645 · 2016-06-30

决定日期2016-06-30

产品代码NHA

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决定实质等同

器械摘要

VITA ENAMIC Implant Solutions (IS) is the device name listed in this FDA 510(k) record. The listed applicant is Vita Zahnfabrik H.Rauter GmbH Co.. It received FDA 510(k) clearance on 2016-06-30 under 510(k) number K153645. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VITA ENAMIC Implant Solutions (IS)?

VITA ENAMIC Implant Solutions (IS) is a medical device that received FDA 510(k) clearance on 2016-06-30. The listed applicant is Vita Zahnfabrik H.Rauter GmbH Co.. The 510(k) number is K153645.

When did VITA ENAMIC Implant Solutions (IS) receive FDA 510(k) clearance?

VITA ENAMIC Implant Solutions (IS) received FDA 510(k) clearance on 2016-06-30, under 510(k) number K153645.

Who is the listed applicant for VITA ENAMIC Implant Solutions (IS)?

The FDA 510(k) record lists Vita Zahnfabrik H.Rauter GmbH Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITA ENAMIC Implant Solutions (IS)?

The FDA product code for VITA ENAMIC Implant Solutions (IS) is NHA.

列明Vita Zahnfabrik H.Rauter GmbH Co.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。

K180703VITA YZ ST 和 VITA YZ XT

相关器械（代码：NHA）

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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官方来源

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