免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

SmartShape™ 恢復式牙根擴張器；寬度客製化铣削 Ti-Blank 牙根擴張器

K 號：K240531 · 2024-07-30

申請人BioHorizons Implant Systems, Inc.
決定日期2024-07-30
產品代碼NHA
諮詢委員會DE
決定相當於

器材摘要

SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment is the device name listed in this FDA 510(k) record. The listed applicant is BioHorizons Implant Systems, Inc.. It received FDA 510(k) clearance on 2024-07-30 under 510(k) number K240531. 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 SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment?

SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment is a medical device that received FDA 510(k) clearance on 2024-07-30. The listed applicant is BioHorizons Implant Systems, Inc.. The 510(k) number is K240531.

When did SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment receive FDA 510(k) clearance?

SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment received FDA 510(k) clearance on 2024-07-30, under 510(k) number K240531.

Who is the listed applicant for SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment?

The FDA 510(k) record lists BioHorizons Implant Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment?

The FDA product code for SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment is NHA.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 BioHorizons Implant Systems, 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。

K260061生物地平線 CEREC 兼容 Ti-BasesK243521錐形Ti基座牙支K240187緩坡型對稱锥形植入系統K223697MRI 兼容現有 BioHorizons 牙齒植體及基座K203252多單位牙根擴大器用於CONELOGK182070生物地平線斜角IM植入體

查看所有 10 項裝置 →

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。

↑