FDA 510(k)

ULab Systems 齿科正畸器套件

K 號：K192596 · 2020-02-11

決定日期2020-02-11

產品代碼NXC

諮詢委員會DE

決定相當於

器材摘要

ULab Systems Dental Aligner Kit is the device name listed in this FDA 510(k) record. The listed applicant is Ulab Systems, Inc.. It received FDA 510(k) clearance on 2020-02-11 under 510(k) number K192596. 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 ULab Systems Dental Aligner Kit?

ULab Systems Dental Aligner Kit is a medical device that received FDA 510(k) clearance on 2020-02-11. The listed applicant is Ulab Systems, Inc.. The 510(k) number is K192596.

When did ULab Systems Dental Aligner Kit receive FDA 510(k) clearance?

ULab Systems Dental Aligner Kit received FDA 510(k) clearance on 2020-02-11, under 510(k) number K192596.

Who is the listed applicant for ULab Systems Dental Aligner Kit?

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

What is the FDA product code for ULab Systems Dental Aligner Kit?

The FDA product code for ULab Systems Dental Aligner Kit is NXC.

其他以 Ulab Systems, Inc. 為申請人之記錄

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K211510uLab Systems 齿齒調整器套件 K200772ULab Systems uDesign 軟體 K171295ULab Systems治療計劃軟體

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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