FDA 510(k)

PANAVIA SA 水泥通用型

K号: K183537 · 2019-04-25

决定日期2019-04-25

产品代码EMA

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决定实质等同

器械摘要

PANAVIA SA Cement Universal is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2019-04-25 under 510(k) number K183537. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PANAVIA SA Cement Universal?

PANAVIA SA Cement Universal is a medical device that received FDA 510(k) clearance on 2019-04-25. The listed applicant is Kuraray Noritake Dental, Inc.. The 510(k) number is K183537.

When did PANAVIA SA Cement Universal receive FDA 510(k) clearance?

PANAVIA SA Cement Universal received FDA 510(k) clearance on 2019-04-25, under 510(k) number K183537.

Who is the listed applicant for PANAVIA SA Cement Universal?

The FDA 510(k) record lists Kuraray Noritake Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PANAVIA SA Cement Universal?

The FDA product code for PANAVIA SA Cement Universal is EMA.

列明Kuraray Noritake Dental, 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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