6MS 隱形正畸器
K 號：K210652 · 2021-06-02
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器材摘要
6MS Invisible Aligner is the device name listed in this FDA 510(k) record. The listed applicant is Sms Opco, LLC. It received FDA 510(k) clearance on 2021-06-02 under 510(k) number K210652. 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 6MS Invisible Aligner?
6MS Invisible Aligner is a medical device that received FDA 510(k) clearance on 2021-06-02. The listed applicant is Sms Opco, LLC. The 510(k) number is K210652.
When did 6MS Invisible Aligner receive FDA 510(k) clearance?
6MS Invisible Aligner received FDA 510(k) clearance on 2021-06-02, under 510(k) number K210652.
Who is the listed applicant for 6MS Invisible Aligner?
The FDA 510(k) record lists Sms Opco, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 6MS Invisible Aligner?
The FDA product code for 6MS Invisible Aligner is NXC.
相關臨床試驗
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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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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