FDA 510(k)

骨心齒植體系統

K 號：K230242 · 2023-10-05

決定日期2023-10-05

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

OsteoCentric Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is OsteoCentric Technologies. It received FDA 510(k) clearance on 2023-10-05 under 510(k) number K230242. 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 OsteoCentric Dental Implant System?

OsteoCentric Dental Implant System is a medical device that received FDA 510(k) clearance on 2023-10-05. The listed applicant is OsteoCentric Technologies. The 510(k) number is K230242.

When did OsteoCentric Dental Implant System receive FDA 510(k) clearance?

OsteoCentric Dental Implant System received FDA 510(k) clearance on 2023-10-05, under 510(k) number K230242.

Who is the listed applicant for OsteoCentric Dental Implant System?

The FDA 510(k) record lists OsteoCentric Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OsteoCentric Dental Implant System?

The FDA product code for OsteoCentric Dental Implant System is DZE.

其他以 OsteoCentric Technologies 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。

K251913OsteoCentric® UnifiMI® TCS 鋼板系統 K250494OsteoCentric 骨板及螺釘系統 K242691OsteoCentric Technologies 穿刺螺釘及螺母 K230226Integrity-SI® 結合系統 K230595骨心臟前交叉韁綁固定系統 K230764骨心整合髋關節固定系統

查看所有 11 項裝置 →

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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