FDA 510(k)

斯特羅曼® BLC植入物 - 指示範圍擴大

K 號：K252168 · 2026-03-10

決定日期2026-03-10

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

Straumann® BLC Implants - Indication Widening is the device name listed in this FDA 510(k) record. The listed applicant is Institut Straumann AG. It received FDA 510(k) clearance on 2026-03-10 under 510(k) number K252168. 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® BLC Implants - Indication Widening?

Straumann® BLC Implants - Indication Widening is a medical device that received FDA 510(k) clearance on 2026-03-10. The listed applicant is Institut Straumann AG. The 510(k) number is K252168.

When did Straumann® BLC Implants - Indication Widening receive FDA 510(k) clearance?

Straumann® BLC Implants - Indication Widening received FDA 510(k) clearance on 2026-03-10, under 510(k) number K252168.

Who is the listed applicant for Straumann® BLC Implants - Indication Widening?

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

What is the FDA product code for Straumann® BLC Implants - Indication Widening?

The FDA product code for Straumann® BLC Implants - Indication Widening is DZE.

其他以 Institut Straumann AG 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。

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官方來源

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