注射式根管生物陶瓷封堵劑（nRoot SP）
K 號：K250710 · 2025-06-11
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器材摘要
Injectable Root Canal Bioceramic Sealer (nRoot SP) is the device name listed in this FDA 510(k) record. The listed applicant is Enpuno Co., Ltd.. It received FDA 510(k) clearance on 2025-06-11 under 510(k) number K250710. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Injectable Root Canal Bioceramic Sealer (nRoot SP)?
Injectable Root Canal Bioceramic Sealer (nRoot SP) is a medical device that received FDA 510(k) clearance on 2025-06-11. The listed applicant is Enpuno Co., Ltd.. The 510(k) number is K250710.
When did Injectable Root Canal Bioceramic Sealer (nRoot SP) receive FDA 510(k) clearance?
Injectable Root Canal Bioceramic Sealer (nRoot SP) received FDA 510(k) clearance on 2025-06-11, under 510(k) number K250710.
Who is the listed applicant for Injectable Root Canal Bioceramic Sealer (nRoot SP)?
The FDA 510(k) record lists Enpuno Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Injectable Root Canal Bioceramic Sealer (nRoot SP)?
The FDA product code for Injectable Root Canal Bioceramic Sealer (nRoot SP) is KIF.
相關臨床試驗
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相關器械（代碼：KIF）
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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