FDA 510(k)

生物地平線 CAD/CAM 牙槽橋

K 號：K151621 · 2016-01-13

決定日期2016-01-13

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

BioHorizons CAD/CAM Abutments 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 2016-01-13 under 510(k) number K151621. 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 BioHorizons CAD/CAM Abutments?

BioHorizons CAD/CAM Abutments is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is BioHorizons Implant Systems, Inc.. The 510(k) number is K151621.

When did BioHorizons CAD/CAM Abutments receive FDA 510(k) clearance?

BioHorizons CAD/CAM Abutments received FDA 510(k) clearance on 2016-01-13, under 510(k) number K151621.

Who is the listed applicant for BioHorizons CAD/CAM Abutments?

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 BioHorizons CAD/CAM Abutments?

The FDA product code for BioHorizons CAD/CAM Abutments is NHA.

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-Bases K243521錐形Ti基座牙支 K240531SmartShape™ 恢復式牙根擴張器；寬度客製化铣削 Ti-Blank 牙根擴張器 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CONELOG

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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, LLC K253999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 AB K261147Neodent植牙系統 - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061生物地平線 CEREC 兼容 Ti-BasesBioHorizons Implant Systems, Inc.

官方來源

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