FDA 510(k)

陶瓷托架

K号: K180952 · 2019-06-07

决定日期2019-06-07

产品代码NJM

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决定实质等同

器械摘要

Ceramic Bracket is the device name listed in this FDA 510(k) record. The listed applicant is Mem Dental Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-06-07 under 510(k) number K180952. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ceramic Bracket?

Ceramic Bracket is a medical device that received FDA 510(k) clearance on 2019-06-07. The listed applicant is Mem Dental Technology Co., Ltd.. The 510(k) number is K180952.

When did Ceramic Bracket receive FDA 510(k) clearance?

Ceramic Bracket received FDA 510(k) clearance on 2019-06-07, under 510(k) number K180952.

Who is the listed applicant for Ceramic Bracket?

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

What is the FDA product code for Ceramic Bracket?

The FDA product code for Ceramic Bracket is NJM.

列明Mem Dental Technology Co., Ltd.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。

K242637MEM Clear正畸系统

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。