FDA 510(k)

客製化隐形正牙器

K 號：K223454 · 2023-04-17

申請人Zhejiang Yinchili Medical Technology Co., Ltd.

決定日期2023-04-17

產品代碼NXC

諮詢委員會DE

決定相當於

器材摘要

Custom-made Invisible Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Yinchili Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-04-17 under 510(k) number K223454. 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 Custom-made Invisible Aligners?

Custom-made Invisible Aligners is a medical device that received FDA 510(k) clearance on 2023-04-17. The listed applicant is Zhejiang Yinchili Medical Technology Co., Ltd.. The 510(k) number is K223454.

When did Custom-made Invisible Aligners receive FDA 510(k) clearance?

Custom-made Invisible Aligners received FDA 510(k) clearance on 2023-04-17, under 510(k) number K223454.

Who is the listed applicant for Custom-made Invisible Aligners?

The FDA 510(k) record lists Zhejiang Yinchili Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Custom-made Invisible Aligners?

The FDA product code for Custom-made Invisible Aligners is NXC.

其他以 Zhejiang Yinchili Medical Technology Co., Ltd. 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。

K203624客製化隐形正牙器

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。

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官方來源

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