URIS長期植入體與基座
K 號：K243255 · 2025-07-03
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器材摘要
URIS Long Implant & Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Truabutment, Inc.. It received FDA 510(k) clearance on 2025-07-03 under 510(k) number K243255. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the URIS Long Implant & Abutments?
URIS Long Implant & Abutments is a medical device that received FDA 510(k) clearance on 2025-07-03. The listed applicant is Truabutment, Inc.. The 510(k) number is K243255.
When did URIS Long Implant & Abutments receive FDA 510(k) clearance?
URIS Long Implant & Abutments received FDA 510(k) clearance on 2025-07-03, under 510(k) number K243255.
Who is the listed applicant for URIS Long Implant & Abutments?
The FDA 510(k) record lists Truabutment, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for URIS Long Implant & Abutments?
The FDA product code for URIS Long Implant & Abutments is DZE.
相關臨床試驗
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其他以 Truabutment, 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：DZE）
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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