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FDA 510(k)

EzDent-i/ E2/ Prora View/ Smart M Viewer

K号: K211795 · 2021-10-04

决定日期2021-10-04
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

EzDent-i/ E2/ Prora View/ Smart M Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Ewoosoft Co., Ltd.. It received FDA 510(k) clearance on 2021-10-04 under 510(k) number K211795. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EzDent-i/ E2/ Prora View/ Smart M Viewer?

EzDent-i/ E2/ Prora View/ Smart M Viewer is a medical device that received FDA 510(k) clearance on 2021-10-04. The listed applicant is Ewoosoft Co., Ltd.. The 510(k) number is K211795.

When did EzDent-i/ E2/ Prora View/ Smart M Viewer receive FDA 510(k) clearance?

EzDent-i/ E2/ Prora View/ Smart M Viewer received FDA 510(k) clearance on 2021-10-04, under 510(k) number K211795.

Who is the listed applicant for EzDent-i/ E2/ Prora View/ Smart M Viewer?

The FDA 510(k) record lists Ewoosoft Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EzDent-i/ E2/ Prora View/ Smart M Viewer?

The FDA product code for EzDent-i/ E2/ Prora View/ Smart M Viewer is LLZ.

相关临床试验

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列明Ewoosoft Co., Ltd.为申报人的其他记录

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相关器械(代码:LLZ)

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。

官方来源

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