FDA 510(k)

Image Fast Set，Image Regular Set

K号: K160097 · 2016-08-05

决定日期2016-08-05

产品代码ELW

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决定实质等同

器械摘要

Image Fast Set, Image Regular Set is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties. It received FDA 510(k) clearance on 2016-08-05 under 510(k) number K160097. 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 Image Fast Set, Image Regular Set?

Image Fast Set, Image Regular Set is a medical device that received FDA 510(k) clearance on 2016-08-05. The listed applicant is Sybron Dental Specialties. The 510(k) number is K160097.

When did Image Fast Set, Image Regular Set receive FDA 510(k) clearance?

Image Fast Set, Image Regular Set received FDA 510(k) clearance on 2016-08-05, under 510(k) number K160097.

Who is the listed applicant for Image Fast Set, Image Regular Set?

The FDA 510(k) record lists Sybron Dental Specialties as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Image Fast Set, Image Regular Set?

The FDA product code for Image Fast Set, Image Regular Set is ELW.

列明Sybron Dental Specialties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：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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