FDA 510(k)

A.B. DENTAL DEVICES 牙齒植入系統

K 號：K162482 · 2017-09-15

決定日期2017-09-15

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

A.B. DENTAL DEVICES Dental Implants System is the device name listed in this FDA 510(k) record. The listed applicant is A.B. Dental Device , Ltd.. It received FDA 510(k) clearance on 2017-09-15 under 510(k) number K162482. 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 A.B. DENTAL DEVICES Dental Implants System?

A.B. DENTAL DEVICES Dental Implants System is a medical device that received FDA 510(k) clearance on 2017-09-15. The listed applicant is A.B. Dental Device , Ltd.. The 510(k) number is K162482.

When did A.B. DENTAL DEVICES Dental Implants System receive FDA 510(k) clearance?

A.B. DENTAL DEVICES Dental Implants System received FDA 510(k) clearance on 2017-09-15, under 510(k) number K162482.

Who is the listed applicant for A.B. DENTAL DEVICES Dental Implants System?

The FDA 510(k) record lists A.B. Dental Device , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A.B. DENTAL DEVICES Dental Implants System?

The FDA product code for A.B. DENTAL DEVICES Dental Implants System is DZE.

其他以 A.B. Dental Device , Ltd. 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。

K202144A.B. Dental Devices 齿科植體系統 K182455A.B. DENTAL DEVICES 牙齒植入系統 K181381A.B. Dental Devices 齿科植體系統

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

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。