FDA 510(k)

清齊正牙器

K 號：K191823 · 2019-12-20

決定日期2019-12-20

產品代碼NXC

諮詢委員會DE

決定相當於

器材摘要

Clear-Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Cdb Corporation. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K191823. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Clear-Aligners?

Clear-Aligners is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Cdb Corporation. The 510(k) number is K191823.

When did Clear-Aligners receive FDA 510(k) clearance?

Clear-Aligners received FDA 510(k) clearance on 2019-12-20, under 510(k) number K191823.

Who is the listed applicant for Clear-Aligners?

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

What is the FDA product code for Clear-Aligners?

The FDA product code for Clear-Aligners is NXC.

其他以 Cdb Corporation 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：NXC）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260527臉部4D調整器Avinent Implant System S.L.U.K260788斯麥麗歐正畸器Smylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile系統Dror Orthodesign , Ltd.K251454清齊正齊器（SCF-3348）Beame Medical Technology (Shenzhen) Limited K250739Primeprint直接對齊器Dreve Dentamid GmbH

官方來源

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