FDA 510(k)

SmileAlign 歸正器系統

K 號：K191774 · 2019-09-30

決定日期2019-09-30

產品代碼NXC

諮詢委員會DE

決定相當於

器材摘要

SmileAlign Orthodontic Aligner System is the device name listed in this FDA 510(k) record. The listed applicant is 3D Global Biotech, Inc.. It received FDA 510(k) clearance on 2019-09-30 under 510(k) number K191774. 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 SmileAlign Orthodontic Aligner System?

SmileAlign Orthodontic Aligner System is a medical device that received FDA 510(k) clearance on 2019-09-30. The listed applicant is 3D Global Biotech, Inc.. The 510(k) number is K191774.

When did SmileAlign Orthodontic Aligner System receive FDA 510(k) clearance?

SmileAlign Orthodontic Aligner System received FDA 510(k) clearance on 2019-09-30, under 510(k) number K191774.

Who is the listed applicant for SmileAlign Orthodontic Aligner System?

The FDA 510(k) record lists 3D Global Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmileAlign Orthodontic Aligner System?

The FDA product code for SmileAlign Orthodontic Aligner System is NXC.

其他以 3D Global Biotech, Inc. 為申請人之記錄

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K212803每日美正畸排齒系統

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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