FDA 510(k)

Ritter 牙齒植體系統

K 號：K180183 · 2019-01-24

決定日期2019-01-24

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

Ritter Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Ritter Implants GmbH & Co. KG. It received FDA 510(k) clearance on 2019-01-24 under 510(k) number K180183. 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 Ritter Dental Implant System?

Ritter Dental Implant System is a medical device that received FDA 510(k) clearance on 2019-01-24. The listed applicant is Ritter Implants GmbH & Co. KG. The 510(k) number is K180183.

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

Ritter Dental Implant System received FDA 510(k) clearance on 2019-01-24, under 510(k) number K180183.

Who is the listed applicant for Ritter Dental Implant System?

The FDA 510(k) record lists Ritter Implants GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

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

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

其他以 Ritter Implants GmbH & Co. KG 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。

K160475Ritter 牙齒植體系統

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。

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官方來源

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