FDA 510(k)

SuperLine

K号: K160965 · 2017-01-13

决定日期2017-01-13

产品代码DZE

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决定实质等同

器械摘要

SuperLine 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 2017-01-13 under 510(k) number K160965. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SuperLine?

SuperLine is a medical device that received FDA 510(k) clearance on 2017-01-13. The listed applicant is Dentium Co., Ltd.. The 510(k) number is K160965.

When did SuperLine receive FDA 510(k) clearance?

SuperLine received FDA 510(k) clearance on 2017-01-13, under 510(k) number K160965.

Who is the listed applicant for SuperLine?

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 SuperLine?

The FDA product code for SuperLine is DZE.

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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官方来源

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