FDA 510(k)

Dentium NR Line CAD/CAM 牙槽基台

K号: K170384 · 2017-08-17

决定日期2017-08-17

产品代码NHA

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决定实质等同

器械摘要

Dentium NR Line CAD/CAM Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Dentium Co., Ltd.. It received FDA 510(k) clearance on 2017-08-17 under 510(k) number K170384. 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 Dentium NR Line CAD/CAM Abutments?

Dentium NR Line CAD/CAM Abutments is a medical device that received FDA 510(k) clearance on 2017-08-17. The listed applicant is Dentium Co., Ltd.. The 510(k) number is K170384.

When did Dentium NR Line CAD/CAM Abutments receive FDA 510(k) clearance?

Dentium NR Line CAD/CAM Abutments received FDA 510(k) clearance on 2017-08-17, under 510(k) number K170384.

Who is the listed applicant for Dentium NR Line CAD/CAM Abutments?

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

What is the FDA product code for Dentium NR Line CAD/CAM Abutments?

The FDA product code for Dentium NR Line CAD/CAM Abutments is NHA.

列明Dentium 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。

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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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