FDA 510(k)

GingiDent 牙龈退缩膏

K号: K162662 · 2017-10-20

决定日期2017-10-20

产品代码MVL

决定实质等同

器械摘要

GingiDent Gingival Retraction Paste is the device name listed in this FDA 510(k) record. The listed applicant is Pac-Dent International, Inc.. It received FDA 510(k) clearance on 2017-10-20 under 510(k) number K162662. The device is classified under product code MVL. FDA Decision: Substantially Equivalent.

常见问题

What is the GingiDent Gingival Retraction Paste?

GingiDent Gingival Retraction Paste is a medical device that received FDA 510(k) clearance on 2017-10-20. The listed applicant is Pac-Dent International, Inc.. The 510(k) number is K162662.

When did GingiDent Gingival Retraction Paste receive FDA 510(k) clearance?

GingiDent Gingival Retraction Paste received FDA 510(k) clearance on 2017-10-20, under 510(k) number K162662.

Who is the listed applicant for GingiDent Gingival Retraction Paste?

The FDA 510(k) record lists Pac-Dent International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GingiDent Gingival Retraction Paste?

The FDA product code for GingiDent Gingival Retraction Paste is MVL.

列明Pac-Dent International, Inc.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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