Invisalign System
K 號：K252380 · 2025-08-29
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器材摘要
Invisalign System is the device name listed in this FDA 510(k) record. The listed applicant is Align Technology, Inc.. It received FDA 510(k) clearance on 2025-08-29 under 510(k) number K252380. 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 Invisalign System?
Invisalign System is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is Align Technology, Inc.. The 510(k) number is K252380.
When did Invisalign System receive FDA 510(k) clearance?
Invisalign System received FDA 510(k) clearance on 2025-08-29, under 510(k) number K252380.
Who is the listed applicant for Invisalign System?
The FDA 510(k) record lists Align Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Invisalign System?
The FDA product code for Invisalign System is NXC.
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其他以 Align Technology, Inc. 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。
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。
K260527FACE4D AlignerAvinent Implant System S.L.U.K260788Smylio AlignersSmylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile SystemDror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) LimitedK250739Primeprint Direct AlignerDreve Dentamid GmbH
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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