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FDA 510(k)

斯特羅曼螺釘固定基座

K 號：K171757 · 2017-11-27

申請人Straumann USA, LLC (On Behalf of Institut Straumann Ag)
決定日期2017-11-27
產品代碼NHA
諮詢委員會DE
決定相當於

器材摘要

Straumann Screw Retained Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA, LLC (On Behalf of Institut Straumann Ag). It received FDA 510(k) clearance on 2017-11-27 under 510(k) number K171757. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Straumann Screw Retained Abutments?

Straumann Screw Retained Abutments is a medical device that received FDA 510(k) clearance on 2017-11-27. The listed applicant is Straumann USA, LLC (On Behalf of Institut Straumann Ag). The 510(k) number is K171757.

When did Straumann Screw Retained Abutments receive FDA 510(k) clearance?

Straumann Screw Retained Abutments received FDA 510(k) clearance on 2017-11-27, under 510(k) number K171757.

Who is the listed applicant for Straumann Screw Retained Abutments?

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

What is the FDA product code for Straumann Screw Retained Abutments?

The FDA product code for Straumann Screw Retained Abutments is NHA.

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其他以 Straumann USA, LLC (On Behalf of Institut Straumann Ag) 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。

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相關器械（代碼：NHA）

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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