FDA 510(k)

Kontact 齿科植體系統

K 號：K213997 · 2022-07-15

決定日期2022-07-15

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

Kontact Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Biotech Dental, Sas. It received FDA 510(k) clearance on 2022-07-15 under 510(k) number K213997. 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 Kontact Dental Implant System?

Kontact Dental Implant System is a medical device that received FDA 510(k) clearance on 2022-07-15. The listed applicant is Biotech Dental, Sas. The 510(k) number is K213997.

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

Kontact Dental Implant System received FDA 510(k) clearance on 2022-07-15, under 510(k) number K213997.

Who is the listed applicant for Kontact Dental Implant System?

The FDA 510(k) record lists Biotech Dental, Sas as the applicant. This does not by itself establish the device manufacturer.

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

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

其他以 Biotech Dental, Sas 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。

K212068生物科技牙科套件 K210220Kontact 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

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