FDA 510(k)

山鹿粉色CAD/CAM光盘

K号: K172683 · 2018-01-16

决定日期2018-01-16

产品代码EBI

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决定实质等同

器械摘要

Yamahachi Pink CAD/CAM Disk is the device name listed in this FDA 510(k) record. The listed applicant is YAMAHACHI DENTAL MFG., Co.. It received FDA 510(k) clearance on 2018-01-16 under 510(k) number K172683. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Yamahachi Pink CAD/CAM Disk?

Yamahachi Pink CAD/CAM Disk is a medical device that received FDA 510(k) clearance on 2018-01-16. The listed applicant is YAMAHACHI DENTAL MFG., Co.. The 510(k) number is K172683.

When did Yamahachi Pink CAD/CAM Disk receive FDA 510(k) clearance?

Yamahachi Pink CAD/CAM Disk received FDA 510(k) clearance on 2018-01-16, under 510(k) number K172683.

Who is the listed applicant for Yamahachi Pink CAD/CAM Disk?

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

What is the FDA product code for Yamahachi Pink CAD/CAM Disk?

The FDA product code for Yamahachi Pink CAD/CAM Disk is EBI.

列明YAMAHACHI DENTAL MFG., Co.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。

K254091GLOSSY COAT (15ML)K233859BASIS FLOW II

官方来源

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