生物潔淨植入修復系統
K 號：K222984 · 2022-12-29
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器材摘要
BioClean Implant Restorative System is the device name listed in this FDA 510(k) record. The listed applicant is Bioclean Dental, LLC. It received FDA 510(k) clearance on 2022-12-29 under 510(k) number K222984. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the BioClean Implant Restorative System?
BioClean Implant Restorative System is a medical device that received FDA 510(k) clearance on 2022-12-29. The listed applicant is Bioclean Dental, LLC. The 510(k) number is K222984.
When did BioClean Implant Restorative System receive FDA 510(k) clearance?
BioClean Implant Restorative System received FDA 510(k) clearance on 2022-12-29, under 510(k) number K222984.
Who is the listed applicant for BioClean Implant Restorative System?
The FDA 510(k) record lists Bioclean Dental, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BioClean Implant Restorative System?
The FDA product code for BioClean Implant Restorative System is NHA.
相關臨床試驗
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相關器械（代碼：NHA）
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。
K262207固定式加長基座Unidental Co., Ltd.K260940貝拉特克條ZimVie US Corp, LLCK253999通用基座 ASC 接合；通用基座 ASC 非接合；通用基座 MUA ASC；臨時基座 接合和非接合；恢復基座 極锥連接；Omnigrip臨床螺釘 鈦金；Omnigrip假牙螺釘Nobel Biocare ABK261147Neodent植牙系統 - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061生物地平線 CEREC 兼容 Ti-BasesBioHorizons Implant Systems, Inc.
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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