FDA 510(k)

KATANA清洁剂，KATANA清洁剂（试验）

K号: K191133 · 2019-10-08

决定日期2019-10-08

产品代码PME

咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。

决定实质等同

器械摘要

KATANA Cleaner, KATANA Cleaner (Trial) 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 2019-10-08 under 510(k) number K191133. The device is classified under product code PME. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the KATANA Cleaner, KATANA Cleaner (Trial)?

KATANA Cleaner, KATANA Cleaner (Trial) is a medical device that received FDA 510(k) clearance on 2019-10-08. The listed applicant is Kuraray Noritake Dental, Inc.. The 510(k) number is K191133.

When did KATANA Cleaner, KATANA Cleaner (Trial) receive FDA 510(k) clearance?

KATANA Cleaner, KATANA Cleaner (Trial) received FDA 510(k) clearance on 2019-10-08, under 510(k) number K191133.

Who is the listed applicant for KATANA Cleaner, KATANA Cleaner (Trial)?

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 KATANA Cleaner, KATANA Cleaner (Trial)?

The FDA product code for KATANA Cleaner, KATANA Cleaner (Trial) is PME.

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。

K250673CERABIEN MiLai K233285KATANA氧化锆ONE用于植入 K231039CLEARFIL Universal Bond Quick 2 K220369Esthetic Colorant K213147CERABIEN MiLai K210504PANAVIA Veneer LC

查看所有 16 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。