FDA 510(k)

Dentium CAD/CAM 牙槽基台

K号: K161713 · 2016-12-16

决定日期2016-12-16

产品代码NHA

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决定实质等同

器械摘要

Dentium 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 2016-12-16 under 510(k) number K161713. 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 CAD/CAM Abutments?

Dentium CAD/CAM Abutments is a medical device that received FDA 510(k) clearance on 2016-12-16. The listed applicant is Dentium Co., Ltd.. The 510(k) number is K161713.

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

Dentium CAD/CAM Abutments received FDA 510(k) clearance on 2016-12-16, under 510(k) number K161713.

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

The FDA product code for Dentium 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。

K213599SuperLine K193341iCTmotor（WL-1）K192436愈合支架和盖螺钉 K191634Scan Abutments and Comfort Caps K172640Dentium Implantium & SuperLine 假牙 K171622Dentium Ti-Base

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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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