FDA 510(k)

華安特客製牙橋

K 號：K221972 · 2023-10-02

決定日期2023-10-02

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Warantec Custom Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Warantec Co., Ltd.. It received FDA 510(k) clearance on 2023-10-02 under 510(k) number K221972. 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 Warantec Custom Abutment?

Warantec Custom Abutment is a medical device that received FDA 510(k) clearance on 2023-10-02. The listed applicant is Warantec Co., Ltd.. The 510(k) number is K221972.

When did Warantec Custom Abutment receive FDA 510(k) clearance?

Warantec Custom Abutment received FDA 510(k) clearance on 2023-10-02, under 510(k) number K221972.

Who is the listed applicant for Warantec Custom Abutment?

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

What is the FDA product code for Warantec Custom Abutment?

The FDA product code for Warantec Custom Abutment is NHA.

其他以 Warantec Co., Ltd. 為申請人之記錄

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K221969IU植入系統基座 K172345IU 嵌入系統

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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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