FDA 510(k)

Allcem, Allcem Core

K号: K183465 · 2019-11-02

决定日期2019-11-02

产品代码EMA

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决定实质等同

器械摘要

Allcem, Allcem Core is the device name listed in this FDA 510(k) record. The listed applicant is Dentscare Ltda. It received FDA 510(k) clearance on 2019-11-02 under 510(k) number K183465. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Allcem, Allcem Core?

Allcem, Allcem Core is a medical device that received FDA 510(k) clearance on 2019-11-02. The listed applicant is Dentscare Ltda. The 510(k) number is K183465.

When did Allcem, Allcem Core receive FDA 510(k) clearance?

Allcem, Allcem Core received FDA 510(k) clearance on 2019-11-02, under 510(k) number K183465.

Who is the listed applicant for Allcem, Allcem Core?

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

What is the FDA product code for Allcem, Allcem Core?

The FDA product code for Allcem, Allcem Core is EMA.

列明Dentscare Ltda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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