FDA 510(k)

每日美正畸排齒系統

K 號：K212803 · 2022-05-23

決定日期2022-05-23

產品代碼NXC

諮詢委員會DE

決定相當於

器材摘要

DailyMate 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 2022-05-23 under 510(k) number K212803. 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 DailyMate Orthodontic Aligner System?

DailyMate Orthodontic Aligner System is a medical device that received FDA 510(k) clearance on 2022-05-23. The listed applicant is 3D Global Biotech, Inc.. The 510(k) number is K212803.

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

DailyMate Orthodontic Aligner System received FDA 510(k) clearance on 2022-05-23, under 510(k) number K212803.

Who is the listed applicant for DailyMate 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 DailyMate Orthodontic Aligner System?

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

其他以 3D Global Biotech, Inc. 為申請人之記錄

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K191774SmileAlign 歸正器系統

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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