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FDA 510(k)

Ziacom 齿科植體系統

K 號:K182908 · 2019-07-18

決定日期2019-07-18
產品代碼DZE
諮詢委員會DE
決定相當於

器材摘要

Ziacom Dental Implant Systems is the device name listed in this FDA 510(k) record. The listed applicant is Ziacom Medical, S.L.. It received FDA 510(k) clearance on 2019-07-18 under 510(k) number K182908. 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 Ziacom Dental Implant Systems?

Ziacom Dental Implant Systems is a medical device that received FDA 510(k) clearance on 2019-07-18. The listed applicant is Ziacom Medical, S.L.. The 510(k) number is K182908.

When did Ziacom Dental Implant Systems receive FDA 510(k) clearance?

Ziacom Dental Implant Systems received FDA 510(k) clearance on 2019-07-18, under 510(k) number K182908.

Who is the listed applicant for Ziacom Dental Implant Systems?

The FDA 510(k) record lists Ziacom Medical, S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ziacom Dental Implant Systems?

The FDA product code for Ziacom Dental Implant Systems is DZE.

相關臨床試驗

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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。

官方來源

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