FDA 510(k)

OsseOne 骨水泥植牙系統

K 號：K182293 · 2019-02-15

決定日期2019-02-15

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

OsseOne Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Synoross Dba Osseone. It received FDA 510(k) clearance on 2019-02-15 under 510(k) number K182293. 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 OsseOne Dental Implant System?

OsseOne Dental Implant System is a medical device that received FDA 510(k) clearance on 2019-02-15. The listed applicant is Synoross Dba Osseone. The 510(k) number is K182293.

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

OsseOne Dental Implant System received FDA 510(k) clearance on 2019-02-15, under 510(k) number K182293.

Who is the listed applicant for OsseOne Dental Implant System?

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

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

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

其他以 Synoross Dba Osseone 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。

K233271OsseOne 骨水泥植牙系統

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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