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FDA 510(k)

HIOSSEN 預製基座（ET 預製基座 & EK 預製基座）

K 號：K241003 · 2025-01-08

申請人Hiossen, Inc.
決定日期2025-01-08
產品代碼NHA
諮詢委員會DE
決定相當於

器材摘要

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) is the device name listed in this FDA 510(k) record. The listed applicant is Hiossen, Inc.. It received FDA 510(k) clearance on 2025-01-08 under 510(k) number K241003. 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 HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)?

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) is a medical device that received FDA 510(k) clearance on 2025-01-08. The listed applicant is Hiossen, Inc.. The 510(k) number is K241003.

When did HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) receive FDA 510(k) clearance?

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) received FDA 510(k) clearance on 2025-01-08, under 510(k) number K241003.

Who is the listed applicant for HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)?

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

What is the FDA product code for HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)?

The FDA product code for HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) is NHA.

相關臨床試驗

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其他以 Hiossen, Inc. 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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官方來源

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