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FDA 510(k)

斯特羅曼 4 毫米 短型植入體

K 號:K202942 · 2021-02-08

決定日期2021-02-08
產品代碼DZE
諮詢委員會DE
決定相當於

器材摘要

Straumann 4 mm Short Implants is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA, LLC. It received FDA 510(k) clearance on 2021-02-08 under 510(k) number K202942. 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 Straumann 4 mm Short Implants?

Straumann 4 mm Short Implants is a medical device that received FDA 510(k) clearance on 2021-02-08. The listed applicant is Straumann USA, LLC. The 510(k) number is K202942.

When did Straumann 4 mm Short Implants receive FDA 510(k) clearance?

Straumann 4 mm Short Implants received FDA 510(k) clearance on 2021-02-08, under 510(k) number K202942.

Who is the listed applicant for Straumann 4 mm Short Implants?

The FDA 510(k) record lists Straumann USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Straumann 4 mm Short Implants?

The FDA product code for Straumann 4 mm Short Implants is DZE.

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其他以 Straumann USA, LLC 為申請人之記錄

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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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