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FDA 510(k)

牙科印模材料

K号: K211489 · 2021-07-28

申请人Nanchang Dental Bright Technology Co., Ltd.
决定日期2021-07-28
产品代码ELW
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决定实质等同

器械摘要

Dental Impression Material is the device name listed in this FDA 510(k) record. The listed applicant is Nanchang Dental Bright Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-07-28 under 510(k) number K211489. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Dental Impression Material?

Dental Impression Material is a medical device that received FDA 510(k) clearance on 2021-07-28. The listed applicant is Nanchang Dental Bright Technology Co., Ltd.. The 510(k) number is K211489.

When did Dental Impression Material receive FDA 510(k) clearance?

Dental Impression Material received FDA 510(k) clearance on 2021-07-28, under 510(k) number K211489.

Who is the listed applicant for Dental Impression Material?

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

What is the FDA product code for Dental Impression Material?

The FDA product code for Dental Impression Material is ELW.

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相关器械（代码：ELW）

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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