HEXIM 嵌入式設備；Samwon 總基座
K 號：K243731 · 2025-07-09
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器材摘要
HEXIM Implant; Samwon General Abutments is the device name listed in this FDA 510(k) record. The listed applicant is P&A USA. It received FDA 510(k) clearance on 2025-07-09 under 510(k) number K243731. 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 HEXIM Implant; Samwon General Abutments?
HEXIM Implant; Samwon General Abutments is a medical device that received FDA 510(k) clearance on 2025-07-09. The listed applicant is P&A USA. The 510(k) number is K243731.
When did HEXIM Implant; Samwon General Abutments receive FDA 510(k) clearance?
HEXIM Implant; Samwon General Abutments received FDA 510(k) clearance on 2025-07-09, under 510(k) number K243731.
Who is the listed applicant for HEXIM Implant; Samwon General Abutments?
The FDA 510(k) record lists P&A USA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HEXIM Implant; Samwon General Abutments?
The FDA product code for HEXIM Implant; Samwon General Abutments is DZE.
相關臨床試驗
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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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