萊昂正畸植入物TAD（臨時固位裝置）
K 號：K242944 · 2025-06-19
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器材摘要
Leone Orthodontic Implant TAD (Temporary Anchorage Device) is the device name listed in this FDA 510(k) record. The listed applicant is Leone S.P.A.. It received FDA 510(k) clearance on 2025-06-19 under 510(k) number K242944. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Leone Orthodontic Implant TAD (Temporary Anchorage Device)?
Leone Orthodontic Implant TAD (Temporary Anchorage Device) is a medical device that received FDA 510(k) clearance on 2025-06-19. The listed applicant is Leone S.P.A.. The 510(k) number is K242944.
When did Leone Orthodontic Implant TAD (Temporary Anchorage Device) receive FDA 510(k) clearance?
Leone Orthodontic Implant TAD (Temporary Anchorage Device) received FDA 510(k) clearance on 2025-06-19, under 510(k) number K242944.
Who is the listed applicant for Leone Orthodontic Implant TAD (Temporary Anchorage Device)?
The FDA 510(k) record lists Leone S.P.A. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Leone Orthodontic Implant TAD (Temporary Anchorage Device)?
The FDA product code for Leone Orthodontic Implant TAD (Temporary Anchorage Device) is OAT.
相關臨床試驗
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：OAT）
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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