FDA 510(k)

緩坡型對稱锥形植入系統

K 號：K240187 · 2024-06-05

決定日期2024-06-05

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

Tapered Pro Conical Implant System 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 2024-06-05 under 510(k) number K240187. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tapered Pro Conical Implant System?

Tapered Pro Conical Implant System is a medical device that received FDA 510(k) clearance on 2024-06-05. The listed applicant is BioHorizons Implant Systems, Inc.. The 510(k) number is K240187.

When did Tapered Pro Conical Implant System receive FDA 510(k) clearance?

Tapered Pro Conical Implant System received FDA 510(k) clearance on 2024-06-05, under 510(k) number K240187.

Who is the listed applicant for Tapered Pro Conical Implant System?

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 Tapered Pro Conical Implant System?

The FDA product code for Tapered Pro Conical Implant System is DZE.

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 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 K182070生物地平線斜角IM植入體

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相關器械（代碼：DZE）

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。

K261392三活牙植體系統Paragon Implant Mfg., LLC K260463ZEROS 齿科植體系統Zeros Co., Ltd.K251188UNIQA® 齿科植體系統Uniqa Dental, Ltd.K251232MegaGen 遺傳子顎骨牙植體系統Megagen Implant Co., Ltd.K250806牙齒植體系統A.B. Dental Devices , Ltd.K260006INOS系統Inosys, Inc.

官方來源

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