EDS生物陶瓷密封劑（Bioseal）
K 號：K202281 · 2021-02-12
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器材摘要
EDS Bioceramic Sealer (Bioseal) is the device name listed in this FDA 510(k) record. The listed applicant is Essential Dental Systems. It received FDA 510(k) clearance on 2021-02-12 under 510(k) number K202281. 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 EDS Bioceramic Sealer (Bioseal)?
EDS Bioceramic Sealer (Bioseal) is a medical device that received FDA 510(k) clearance on 2021-02-12. The listed applicant is Essential Dental Systems. The 510(k) number is K202281.
When did EDS Bioceramic Sealer (Bioseal) receive FDA 510(k) clearance?
EDS Bioceramic Sealer (Bioseal) received FDA 510(k) clearance on 2021-02-12, under 510(k) number K202281.
Who is the listed applicant for EDS Bioceramic Sealer (Bioseal)?
The FDA 510(k) record lists Essential Dental Systems as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EDS Bioceramic Sealer (Bioseal)?
The FDA product code for EDS Bioceramic Sealer (Bioseal) 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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